Back to results"Post-acute Pickwick Study" (Postacute-Pick-2020)
Primary Purpose
Acute on Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome (OHS)
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Lifestyle modifications" group (Control)
Automatic NIV
CPAP treatment group
NIV treatment groups
Sponsored by
About this trial
This is an interventional treatment trial for Acute on Chronic Hypercapnic Respiratory Failure focused on measuring Hypercapnic respiratory failure, Obesity, Non invasive mechanical ventilation, CPAP
Eligibility Criteria
Inclusion Criteria:
- º.- Patient between 18 and 85 years old.
- º.- With diagnosis of OHS (according to Obesity (BMI ≥30 kg/m2) and Hypercapnic respiratory failure (PaCO2 ≥45 mmHg at hospital discharge) not secondary to other causes.
- º - Hospitalized for an episode of acute-on-chronic hypercapnic respiratory failure, receiving hospital therapy with invasive or noninvasive ventilation, and just deemed stable for home discharge."
- º.- No NIV or CPAP home therapy in the last 6 months[*].
- º.- Being able to tolerate and correctly execute a 15-minute test with automatic NIV (AVAPS-AE) and another 15-minute test with fixed CPAP treatments during wakefulness.
- º.- Providing informed consent (dated and signed).
[*] Patients who have objective evidence of minimal PAP therapy during the 6 months prior to hospital admission (i.e. average daily use of less than 2 hours of PAP therapy) can also be enrolled at the discretion of the investigators if they feel the patient is now more interested in being adherent to NIV therapy.
Inclusion criteria for the second phase of the study:
1º.- Included three months ago in the first phase of the study (followed by a washout period of 5 days).
Exclusion Criteria:
Exclusion criteria for the first phase of the study:
- º.- With moderate or severe chronic obstructive pulmonary disease (FEV1<70% of predicted when FEV1/FVC is below 70%).
- º.- With neuromuscular disease, thoracic wall or metabolic disease that may cause diurnal hypercapnia.
- º.- Inability to maintain a patent airway or adequately clear secretions.
- º.- With bullous lung disease or with pneumothorax.
- º.- With bypassed upper airway (i.e. endotracheal tube or tracheostomy).
- º.- With anatomical abnormalities of the craniofacial structure leading to cerebral spinal fluid leaks, abnormalities of the cribriform plate, and/or pneumocephalus.
- º.- At risk for aspiration of gastric contents.
- º.- Diagnosed with acute sinusitis or otitis media.
- º.- With active hemoptysis or epistaxis if presenting a risk of causing pulmonary aspiration of blood.
- º.- With symptomatic hypotension.
- º.- With clinical diagnosis of narcolepsy or restless leg syndrome.
- º.- Psycho-physical incapacity to complete questionnaires.
- º.- With diagnosis of chronic illness that might interfere the evaluation using quality of life questionnaires (neoplasia, severe chronic pain of any type, and any other severe chronic debilitating illness).
- º.- Suffering other clinically relevant disease that, under the opinion of the investigator, might affect the evaluations of efficacy or safety.
- º.- Participating simultaneously in other clinical study with intervention (or without intervention at the discretion of the investigator and with the consent of the Sponsor) or had participated in other clinical study with intervention within the last 30 days before the inclusion in this study. [‡]
- º.- If for any reason (planned surgery [including bariatric surgery], trips of long duration, etc.) would not be able to receive the treatment and/or attend the follow-up visits of this study within the next three years and three months.
- º.- Persons deprived of liberty by judicial or administrative decision, persons under psychiatric treatment and persons placed in a health or social institution for purposes other than those of this clinical study.
- º.- Adults who are subject to a legal protection measure or who are unable to express their consent.
[‡] This prohibition shall be maintained for the duration of the patients' participation in the study. This is because, if patients received other treatments, it could be difficult to interpret the causality of the results obtained (whether beneficial or harmful effects) and the possible contraindications.
vi. Exclusion criteria for the second phase of the study:
1º.- With apnea hypopnea index (AHI) lower than 5 (absence or very mild obstructive sleep apnea).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Life style modification
Life style modificacion and automatic NIV(AVAPS-AE)
Life style modification and titrated NIV(S/T mode)
Life style modification and titrated CPAP
Arm Description
"Lifestyle modifications" group (Control) will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88)
Automatic NIV: In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 20 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight. These parameters may be modified according to patient tolerance or non-compensated leak.
In-laboratory polysomnographic NIV titration will be performed according to published guidelines (Berry R et al JCSM 2010). In addition to lifestyle modification and oxygen (if required), home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel PAP with backup respiratory rate (BIPAP S/T mode). The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG.
In-laboratory polysomnographic CPAP titration will be performed according to published guidelines (SEPAR guideline or AASM guideline). In addition to lifestyle modification and oxygen (if required), home CPAP therapy at a fixed pressure will be initiated.
Outcomes
Primary Outcome Measures
Medium-term composite hospital resource utilization-mortality
Primary (medium-term from the first phase or RCT): the medium-term efficacy of automatic NIV treatment versus "lifestyle modifications" treatment in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
Long-term composite hospital resource utilization-mortality
Primary (long-term from the second phase or RCT): the long-term efficacy of titrated CPAP therapy versus titrated NIV therapy in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
Secondary Outcome Measures
Hospital admissions
Separately the components of the primary outcome: hospital admissions measured as the number of events
ICU admissions
Separately the components of the primary outcome: ICU admissions measured as the number of events
Emergency department visits
Separately the components of the primary outcome: emergency department visits for any cause measured as the number of events
All-cause mortality
Separately the components of the primary outcome: All-cause mortality number
Duration of hospital admissions
Duration of hospital admissions measured in days of hospital admission
Duration of ICU admissions
Duration of ICU admissions measured in days of ICU admission
Number of patients who change of the allocated arms
Number of patients who change of the allocated arms
Causes of change of the allocated treatment
Causes of change of the allocated arms
Clinical symptoms: lower extremity edema
Number of patients into four levels of frequency (no, sometimes, usually and always)
Clinical symptoms: unrefreshing sleep
Number of patients into four levels of frequency (no, sometimes, usually and always)
Clinical symptoms: morning fatigue
Number of patients into four levels of frequency (no, sometimes, usually and always)
Clinical symptoms: nocturia
Number of patients into four levels of frequency (no, sometimes, usually and always)
Clinical symptoms: headache
Number of patients into four levels of frequency (no, sometimes, usually and always)
Clinical symptoms: tiredness
Number of patients into four levels of frequency (no, sometimes, usually and always)
Clinical symptoms: morning confusion
Number of patients into four levels of frequency (no, sometimes, usually and always)
Clinical symptoms: dysnea
Number of patients with dysnea according to the Medical Research Council scale classified into five levels of intensity (from 0 to 4)
Clinical symptoms: sleepiness
Level of perceived sleepiness measured by the Epworth Sleepiness Scale
Health related quality of life (HRQL): Functional Outcomes of Sleep Questionnaire-- FOSQ--
Scoring of Functional Outcomes of Sleep Questionnaire-- FOSQ---
Health related quality of life (HRQL): European health-related quality of life questionnaire (EuroQol) EQ-5D-5L
Scoring of European health-related quality of life questionnaire (EuroQol) EQ-5D-5L
Health related quality of life (HRQL): Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) (EuroQol) EQ-5D-5L
Scoring of Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) measured in percentage.
Arterial blood gases (ABG): PaO2
PaO2 in mmHg
Arterial blood gases (ABG): PaCO2
PaCO2 in mmHg
Arterial blood gases (ABG): Bicarbonate
bicarbonate measured in mmol/L
Arterial blood gases (ABG): pH
pH
Weight
weight in Kg
Standardized blood pressure measures
Systolic and diastolic blood pressure measured in mmHg
Incidence of cardiovascular events: systemic hypertension
Incidence of hypertension diagnosis or initiation of a new anti-hypertensive treatment
Incidence of cardiovascular events: arrhythmia
Incidence of arrhythmia
Incidence of cardiovascular events: nonfatal myocardial infarction
Incidence of nonfatal myocardial infarction
Incidence of cardiovascular events: hospitalization for unstable angina
Incidence of hospitalization for unstable angina
Incidence of cardiovascular events: coronary percutaneous interventions
Incidence of coronary percutaneous interventions
Incidence of cardiovascular events: nonfatal stroke or transient ischemic attack
Incidence of nonfatal stroke or transient ischemic attack
Incidence of cardiovascular events: heart failure episode
Incidence of heart failure episode
Incidence of cardiovascular events: cardiovascular death
Incidence of cardiovascular death.
Incidence of adverse event
Number of adverse events according to Treatment-Related Adverse Events as assessed by CTCAE v5.0
Cost-effectiveness analysis based on the primary outcome and quality adjusted life year (QALY)
Differences in within trial costs will be related with the differences in effectiveness (primary outcome and QALY) between arms using a probabilistic approach to calculate the cost-effectiveness plane.
Number of oro-tracheal intubation
Number of the tracheal intubations
Duration of tracheal intubation
Duration of tracheal intubation
Full Information
NCT ID
NCT04317326
First Posted
February 14, 2020
Last Updated
May 9, 2023
Sponsor
Juan F. Masa
Collaborators
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04317326
Brief Title
"Post-acute Pickwick Study" (Postacute-Pick-2020)
Official Title
"Mid- and Long-term Effectiveness of Positive Airway Pressure in OHS After an Acute-on-chronic Hypercapnic Respiratory Failure"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
due to the "Philips alert " we could not get the treatment equipment and the public grands expired
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan F. Masa
Collaborators
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.
Detailed Description
Objectives: First phase (medium-term): To evaluate the medium-term (3 months) efficacy of automatically adjusted noninvasive ventilation (NIV) treatment versus "life style modifications" treatment in obesity hypoventilation syndrome (OHS) after an episode of acute-on-chronic hypercapnic respiratory failure. The main outcome will be a composite that includes hospital resource utilization (hospital and ICU admissions and emergency department visits for any cause) and all-cause mortality. Key secondary outcomes will include incident cardiovascular events (new hypertension diagnosis or initiation of anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or unstable angina, percutaneous coronary interventions, nonfatal stroke or transient ischemic attack or for acute heart failure episode, and cardiovascular death), blood pressure, arterial blood gases, clinical symptoms and quality of life. Second phase (long-term): Evaluate the long-term efficacy (36 months) of manually titrated NIV treatment versus manually titrated CPAP treatment in OHS after 3 months of an episode of acute-on-chronic hypercapnic respiratory failure, with a composite outcome of hospital resource utilization (hospital and ICU admissions, emergency department visits) and all-cause mortality analyzed as the primary outcome. Incident cardiovascular events, blood pressure, arterial blood gases, clinical symptoms and quality of life will be the main secondary outcomes.
Methods: Prospective, multinational, randomized open-label controlled trial with two parallel arms: 1,110 hospitalized patients with newly diagnosed OHS with acute-on-chronic hypercapnic respiratory failure treated with invasive or noninvasive mechanical ventilation who survive hospitalization and available for hospital discharge will be randomized to either automatically adjusted NIV (555 patients) or "life style modifications" (555 patients) for three months. Subsequently, both automatically adjusted NIV and "life style modifications" arms will be re-randomized to polysomnographically adjusted CPAP or to polysomnographically adjusted NIV groups to complete 36 months of follow up. The first phase of the proposal is a superiority study and the second phase is a non-inferiority study. The primary outcome and its components will be analyzed by a mixed-effects model with negative binomial. A mixed-effects Cox model will be used for hospital resource utilization, new cardiovascular events and overall survival. Other secondary outcomes such as repeated measures derived from the arterial blood gases (i.e. PaCO2, PaO2, pH, calculated bicarbonate), blood pressure, health-related quality of life tests and Epworth Sleepiness Scale during the follow-up will be analyzed by a linear mixed-effects model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome (OHS)
Keywords
Hypercapnic respiratory failure, Obesity, Non invasive mechanical ventilation, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, open label, randomized controlled trial with two sequential phases
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Life style modification
Arm Type
Experimental
Arm Description
"Lifestyle modifications" group (Control) will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88)
Arm Title
Life style modificacion and automatic NIV(AVAPS-AE)
Arm Type
Active Comparator
Arm Description
Automatic NIV: In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 20 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight. These parameters may be modified according to patient tolerance or non-compensated leak.
Arm Title
Life style modification and titrated NIV(S/T mode)
Arm Type
Experimental
Arm Description
In-laboratory polysomnographic NIV titration will be performed according to published guidelines (Berry R et al JCSM 2010). In addition to lifestyle modification and oxygen (if required), home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel PAP with backup respiratory rate (BIPAP S/T mode). The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG.
Arm Title
Life style modification and titrated CPAP
Arm Type
Active Comparator
Arm Description
In-laboratory polysomnographic CPAP titration will be performed according to published guidelines (SEPAR guideline or AASM guideline). In addition to lifestyle modification and oxygen (if required), home CPAP therapy at a fixed pressure will be initiated.
Intervention Type
Procedure
Intervention Name(s)
"Lifestyle modifications" group (Control)
Intervention Description
It will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88). The treatment period will be three months.
Intervention Type
Procedure
Intervention Name(s)
Automatic NIV
Intervention Description
In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 18 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight, being able to be modified according to tolerance.The treatment period will be three months.
Intervention Type
Procedure
Intervention Name(s)
CPAP treatment group
Intervention Description
In-laboratory polysomnographic CPAP titration will be performed according to published guidelines for CPAP titration (SEPAR guideline or AASM guideline).In addition to lifestyle modification and oxygen (if require), a home titrated CPAP therapy will be initiated.The treatment period will be three years.
Intervention Type
Procedure
Intervention Name(s)
NIV treatment groups
Intervention Description
In-laboratory polysomnographic NIV titration will be performed according to published guidelines In addition to lifestyle modification and oxygen (if required) home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel pressure in S/T mode. The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. The treatment period will be three years.
Primary Outcome Measure Information:
Title
Medium-term composite hospital resource utilization-mortality
Description
Primary (medium-term from the first phase or RCT): the medium-term efficacy of automatic NIV treatment versus "lifestyle modifications" treatment in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
Time Frame
3 months
Title
Long-term composite hospital resource utilization-mortality
Description
Primary (long-term from the second phase or RCT): the long-term efficacy of titrated CPAP therapy versus titrated NIV therapy in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Hospital admissions
Description
Separately the components of the primary outcome: hospital admissions measured as the number of events
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
ICU admissions
Description
Separately the components of the primary outcome: ICU admissions measured as the number of events
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Emergency department visits
Description
Separately the components of the primary outcome: emergency department visits for any cause measured as the number of events
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
All-cause mortality
Description
Separately the components of the primary outcome: All-cause mortality number
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Duration of hospital admissions
Description
Duration of hospital admissions measured in days of hospital admission
Time Frame
During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Title
Duration of ICU admissions
Description
Duration of ICU admissions measured in days of ICU admission
Time Frame
During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Title
Number of patients who change of the allocated arms
Description
Number of patients who change of the allocated arms
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Causes of change of the allocated treatment
Description
Causes of change of the allocated arms
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Clinical symptoms: lower extremity edema
Description
Number of patients into four levels of frequency (no, sometimes, usually and always)
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
Clinical symptoms: unrefreshing sleep
Description
Number of patients into four levels of frequency (no, sometimes, usually and always)
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
Clinical symptoms: morning fatigue
Description
Number of patients into four levels of frequency (no, sometimes, usually and always)
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Clinical symptoms: nocturia
Description
Number of patients into four levels of frequency (no, sometimes, usually and always)
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Clinical symptoms: headache
Description
Number of patients into four levels of frequency (no, sometimes, usually and always)
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Clinical symptoms: tiredness
Description
Number of patients into four levels of frequency (no, sometimes, usually and always)
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Clinical symptoms: morning confusion
Description
Number of patients into four levels of frequency (no, sometimes, usually and always)
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Clinical symptoms: dysnea
Description
Number of patients with dysnea according to the Medical Research Council scale classified into five levels of intensity (from 0 to 4)
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Clinical symptoms: sleepiness
Description
Level of perceived sleepiness measured by the Epworth Sleepiness Scale
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Health related quality of life (HRQL): Functional Outcomes of Sleep Questionnaire-- FOSQ--
Description
Scoring of Functional Outcomes of Sleep Questionnaire-- FOSQ---
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
Health related quality of life (HRQL): European health-related quality of life questionnaire (EuroQol) EQ-5D-5L
Description
Scoring of European health-related quality of life questionnaire (EuroQol) EQ-5D-5L
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Health related quality of life (HRQL): Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) (EuroQol) EQ-5D-5L
Description
Scoring of Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) measured in percentage.
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Arterial blood gases (ABG): PaO2
Description
PaO2 in mmHg
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Arterial blood gases (ABG): PaCO2
Description
PaCO2 in mmHg
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Arterial blood gases (ABG): Bicarbonate
Description
bicarbonate measured in mmol/L
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Arterial blood gases (ABG): pH
Description
pH
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Weight
Description
weight in Kg
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Standardized blood pressure measures
Description
Systolic and diastolic blood pressure measured in mmHg
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: systemic hypertension
Description
Incidence of hypertension diagnosis or initiation of a new anti-hypertensive treatment
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: arrhythmia
Description
Incidence of arrhythmia
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: nonfatal myocardial infarction
Description
Incidence of nonfatal myocardial infarction
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: hospitalization for unstable angina
Description
Incidence of hospitalization for unstable angina
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: coronary percutaneous interventions
Description
Incidence of coronary percutaneous interventions
Time Frame
After 3 months and after 3 years for first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: nonfatal stroke or transient ischemic attack
Description
Incidence of nonfatal stroke or transient ischemic attack
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: heart failure episode
Description
Incidence of heart failure episode
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Incidence of cardiovascular events: cardiovascular death
Description
Incidence of cardiovascular death.
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Incidence of adverse event
Description
Number of adverse events according to Treatment-Related Adverse Events as assessed by CTCAE v5.0
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Cost-effectiveness analysis based on the primary outcome and quality adjusted life year (QALY)
Description
Differences in within trial costs will be related with the differences in effectiveness (primary outcome and QALY) between arms using a probabilistic approach to calculate the cost-effectiveness plane.
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Number of oro-tracheal intubation
Description
Number of the tracheal intubations
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Title
Duration of tracheal intubation
Description
Duration of tracheal intubation
Time Frame
During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Other Pre-specified Outcome Measures:
Title
A composite outcome in adherent vs. non-adherent to PAP therapy subgroups
Description
Efficacy of automatic NIV treatment versus "lifestyle modifications" treatment measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events comparing adherent vs. non-adherent to PAP therapy subgroups (lower and higher of a mean of 4 h/day)
Time Frame
During 3 months for the first phase or RCT
Title
A composite outcome in adherent vs. non-adherent to PAP therapy subgroups
Description
Efficacy of automatic NIV treatment versus CPAP treatment measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events comparing adherent vs. non-adherent to PAP therapy subgroups (lower and higher of a mean of 4 h/days)
Time Frame
During 3 years for the second phase or RCT
Title
Subgroups according to whether hypercapnia was resolved or not
Description
Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with PaCO2 higher or lower of 45 mmHg at the end of follow-up
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
A composite outcome in subgroups with or without supplemental oxygen at baseline
Description
Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with or without supplemental oxygen therapy at baseline
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
A composite outcome in subgroups of hypercapnia severity at baseline
Description
Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with higher and lower hypercapnia at baseline (above and below of the median PaCO2 measured in mmHg)
Time Frame
During 3 months and During 3 years for first and second phases or sequential RCTs respectively
Title
A composite outcome in subgroups of the apnea-hypopnea index severity at baseline
Description
Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with higher and lower apnea-hypopnea index at baseline (above and below of the median apnea-hypopnea index at baseline)
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
A composite outcome in subgroups with or without hypertension diagnosis at baseline
Description
Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with or without hypertension diagnosis at baseline
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
A composite outcome in subgroups with different home care providers
Description
Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with different home care providers (i.e. AirLiquide)
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Title
Validity analysis of EQ 5D-5L test
Description
To perform a validity analysis of EQ 5D-5L test
Time Frame
During 3 months and during 3 years for first and second phases or sequential RCTs respectively
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
º.- Patient between 18 and 85 years old.
º.- With diagnosis of OHS (according to Obesity (BMI ≥30 kg/m2) and Hypercapnic respiratory failure (PaCO2 ≥45 mmHg at hospital discharge) not secondary to other causes.
º - Hospitalized for an episode of acute-on-chronic hypercapnic respiratory failure, receiving hospital therapy with invasive or noninvasive ventilation, and just deemed stable for home discharge."
º.- No NIV or CPAP home therapy in the last 6 months[*].
º.- Being able to tolerate and correctly execute a 15-minute test with automatic NIV (AVAPS-AE) and another 15-minute test with fixed CPAP treatments during wakefulness.
º.- Providing informed consent (dated and signed).
[*] Patients who have objective evidence of minimal PAP therapy during the 6 months prior to hospital admission (i.e. average daily use of less than 2 hours of PAP therapy) can also be enrolled at the discretion of the investigators if they feel the patient is now more interested in being adherent to NIV therapy.
Inclusion criteria for the second phase of the study:
1º.- Included three months ago in the first phase of the study (followed by a washout period of 5 days).
Exclusion Criteria:
Exclusion criteria for the first phase of the study:
º.- With moderate or severe chronic obstructive pulmonary disease (FEV1<70% of predicted when FEV1/FVC is below 70%).
º.- With neuromuscular disease, thoracic wall or metabolic disease that may cause diurnal hypercapnia.
º.- Inability to maintain a patent airway or adequately clear secretions.
º.- With bullous lung disease or with pneumothorax.
º.- With bypassed upper airway (i.e. endotracheal tube or tracheostomy).
º.- With anatomical abnormalities of the craniofacial structure leading to cerebral spinal fluid leaks, abnormalities of the cribriform plate, and/or pneumocephalus.
º.- At risk for aspiration of gastric contents.
º.- Diagnosed with acute sinusitis or otitis media.
º.- With active hemoptysis or epistaxis if presenting a risk of causing pulmonary aspiration of blood.
º.- With symptomatic hypotension.
º.- With clinical diagnosis of narcolepsy or restless leg syndrome.
º.- Psycho-physical incapacity to complete questionnaires.
º.- With diagnosis of chronic illness that might interfere the evaluation using quality of life questionnaires (neoplasia, severe chronic pain of any type, and any other severe chronic debilitating illness).
º.- Suffering other clinically relevant disease that, under the opinion of the investigator, might affect the evaluations of efficacy or safety.
º.- Participating simultaneously in other clinical study with intervention (or without intervention at the discretion of the investigator and with the consent of the Sponsor) or had participated in other clinical study with intervention within the last 30 days before the inclusion in this study. [‡]
º.- If for any reason (planned surgery [including bariatric surgery], trips of long duration, etc.) would not be able to receive the treatment and/or attend the follow-up visits of this study within the next three years and three months.
º.- Persons deprived of liberty by judicial or administrative decision, persons under psychiatric treatment and persons placed in a health or social institution for purposes other than those of this clinical study.
º.- Adults who are subject to a legal protection measure or who are unable to express their consent.
[‡] This prohibition shall be maintained for the duration of the patients' participation in the study. This is because, if patients received other treatments, it could be difficult to interpret the causality of the results obtained (whether beneficial or harmful effects) and the possible contraindications.
vi. Exclusion criteria for the second phase of the study:
1º.- With apnea hypopnea index (AHI) lower than 5 (absence or very mild obstructive sleep apnea).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F Masa, MD, Phd
Organizational Affiliation
Servicio Extremeño de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Babak Mokhlesi, MD, Prof
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Additional related documents such as study protocol, statistical analysis plan, and informed consent form will be available upon request from the Project principal investigator (Dr. Juan Fernando Masa). Deidentified patients' data can be requested by researchers for use in independent scientific research and will be provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa- fmasa@separ.es).
IPD Sharing Time Frame
2 years after the publication of this tria
IPD Sharing Access Criteria
Requests should be sent to the corresponding authors (Dr. Juan Fernando Masa- fmasa@separ.es; and Dr Babak Mokhlesi- Babak_Mokhlesi@rush.edu).
Citations:
PubMed Identifier
16963680
Citation
Storre JH, Seuthe B, Fiechter R, Milioglou S, Dreher M, Sorichter S, Windisch W. Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Chest. 2006 Sep;130(3):815-21. doi: 10.1378/chest.130.3.815.
Results Reference
background
PubMed Identifier
11029353
Citation
Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019.
Results Reference
result
PubMed Identifier
10080847
Citation
Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
Results Reference
result
PubMed Identifier
15781100
Citation
Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
Results Reference
result
PubMed Identifier
11502631
Citation
Kessler R, Chaouat A, Schinkewitch P, Faller M, Casel S, Krieger J, Weitzenblum E. The obesity-hypoventilation syndrome revisited: a prospective study of 34 consecutive cases. Chest. 2001 Aug;120(2):369-76. doi: 10.1378/chest.120.2.369.
Results Reference
result
PubMed Identifier
25915102
Citation
Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.
Results Reference
result
PubMed Identifier
25671545
Citation
Castro-Anon O, Perez de Llano LA, De la Fuente Sanchez S, Golpe R, Mendez Marote L, Castro-Castro J, Gonzalez Quintela A. Obesity-hypoventilation syndrome: increased risk of death over sleep apnea syndrome. PLoS One. 2015 Feb 11;10(2):e0117808. doi: 10.1371/journal.pone.0117808. eCollection 2015.
Results Reference
result
PubMed Identifier
24028180
Citation
Basoglu OK, Tasbakan MS. Comparison of clinical characteristics in patients with obesity hypoventilation syndrome and obese obstructive sleep apnea syndrome: a case-control study. Clin Respir J. 2014 Apr;8(2):167-74. doi: 10.1111/crj.12054. Epub 2013 Nov 28.
Results Reference
result
PubMed Identifier
20348200
Citation
Priou P, Hamel JF, Person C, Meslier N, Racineux JL, Urban T, Gagnadoux F. Long-term outcome of noninvasive positive pressure ventilation for obesity hypoventilation syndrome. Chest. 2010 Jul;138(1):84-90. doi: 10.1378/chest.09-2472. Epub 2010 Mar 26.
Results Reference
result
PubMed Identifier
11502632
Citation
Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377.
Results Reference
result
PubMed Identifier
29146865
Citation
Corral J, Mogollon MV, Sanchez-Quiroga MA, Gomez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, de Lucas P, Marin JM, Romero O, Diaz-Cambriles T, Chiner E, Egea C, Lang RM, Mokhlesi B, Masa JF; Spanish Sleep Network. Echocardiographic changes with non-invasive ventilation and CPAP in obesity hypoventilation syndrome. Thorax. 2018 Apr;73(4):361-368. doi: 10.1136/thoraxjnl-2017-210642. Epub 2017 Nov 16.
Results Reference
result
PubMed Identifier
26923627
Citation
Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network( *). Protective Cardiovascular Effect of Sleep Apnea Severity in Obesity Hypoventilation Syndrome. Chest. 2016 Jul;150(1):68-79. doi: 10.1016/j.chest.2016.02.647. Epub 2016 Feb 27.
Results Reference
result
PubMed Identifier
12082446
Citation
Weitzenblum E, Kessler R, Chaouat A. [Alveolar hypoventilation in the obese: the obesity-hypoventilation syndrome]. Rev Pneumol Clin. 2002 Apr;58(2):83-90. French.
Results Reference
result
PubMed Identifier
10414409
Citation
Chaouat A, Weitzenblum E, Krieger J, Sforza E, Hammad H, Oswald M, Kessler R. Prognostic value of lung function and pulmonary haemodynamics in OSA patients treated with CPAP. Eur Respir J. 1999 May;13(5):1091-6. doi: 10.1034/j.1399-3003.1999.13e25.x.
Results Reference
result
PubMed Identifier
10555090
Citation
Biring MS, Lewis MI, Liu JT, Mohsenifar Z. Pulmonary physiologic changes of morbid obesity. Am J Med Sci. 1999 Nov;318(5):293-7. doi: 10.1097/00000441-199911000-00002.
Results Reference
result
PubMed Identifier
1935291
Citation
Leech J, Onal E, Aronson R, Lopata M. Voluntary hyperventilation in obesity hypoventilation. Chest. 1991 Nov;100(5):1334-8. doi: 10.1378/chest.100.5.1334.
Results Reference
result
PubMed Identifier
1163544
Citation
Zwillich CW, Sutton FD, Pierson DJ, Greagh EM, Weil JV. Decreased hypoxic ventilatory drive in the obesity-hypoventilation syndrome. Am J Med. 1975 Sep;59(3):343-8. doi: 10.1016/0002-9343(75)90392-7.
Results Reference
result
PubMed Identifier
5419916
Citation
MacGregor MI, Block AJ, Ball WC Jr. Topics in clinical medicine: serious complications and sudden death in the Pickwickian syndrome. Johns Hopkins Med J. 1970 May;126(5):279-95. No abstract available.
Results Reference
result
PubMed Identifier
4812072
Citation
Miller A, Granada M. In-hospital mortality in the Pickwickian syndrome. Am J Med. 1974 Feb;56(2):144-50. doi: 10.1016/0002-9343(74)90591-9. No abstract available.
Results Reference
result
PubMed Identifier
21199816
Citation
Jennum P, Kjellberg J. Health, social and economical consequences of sleep-disordered breathing: a controlled national study. Thorax. 2011 Jul;66(7):560-6. doi: 10.1136/thx.2010.143958. Epub 2011 Jan 2.
Results Reference
result
PubMed Identifier
16164877
Citation
Olson AL, Zwillich C. The obesity hypoventilation syndrome. Am J Med. 2005 Sep;118(9):948-56. doi: 10.1016/j.amjmed.2005.03.042.
Results Reference
result
PubMed Identifier
11591566
Citation
Berger KI, Ayappa I, Chatr-Amontri B, Marfatia A, Sorkin IB, Rapoport DM, Goldring RM. Obesity hypoventilation syndrome as a spectrum of respiratory disturbances during sleep. Chest. 2001 Oct;120(4):1231-8. doi: 10.1378/chest.120.4.1231.
Results Reference
result
PubMed Identifier
27406165
Citation
Masa JF, Corral J, Caballero C, Barrot E, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Miranda E, Mokhlesi B; Spanish Sleep Network; Garcia-Ledesma E, Sanchez-Quiroga MA, Ordax E, Gonzalez-Mangado N, Troncoso MF, Martinez-Martinez MA, Cantalejo O, Ojeda E, Carrizo SJ, Gallego B, Pallero M, Ramon MA, Diaz-de-Atauri J, Munoz-Mendez J, Senent C, Sancho-Chust JN, Ribas-Solis FJ, Romero A, Benitez JM, Sanchez-Gomez J, Golpe R, Santiago-Recuerda A, Gomez S, Bengoa M. Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea. Thorax. 2016 Oct;71(10):899-906. doi: 10.1136/thoraxjnl-2016-208501. Epub 2016 Jul 12.
Results Reference
result
PubMed Identifier
30935737
Citation
Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Teran-Santos J, Alonso-Alvarez ML, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Long-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1721-1732. doi: 10.1016/S0140-6736(18)32978-7. Epub 2019 Mar 29.
Results Reference
result
PubMed Identifier
20875161
Citation
Mokhlesi B. Obesity hypoventilation syndrome: a state-of-the-art review. Respir Care. 2010 Oct;55(10):1347-62; discussion 1363-5.
Results Reference
result
PubMed Identifier
18538199
Citation
Lee WY, Mokhlesi B. Diagnosis and management of obesity hypoventilation syndrome in the ICU. Crit Care Clin. 2008 Jul;24(3):533-49, vii. doi: 10.1016/j.ccc.2008.02.003.
Results Reference
result
PubMed Identifier
20957853
Citation
Berry RB, Chediak A, Brown LK, Finder J, Gozal D, Iber C, Kushida CA, Morgenthaler T, Rowley JA, Davidson-Ward SL; NPPV Titration Task Force of the American Academy of Sleep Medicine. Best clinical practices for the sleep center adjustment of noninvasive positive pressure ventilation (NPPV) in stable chronic alveolar hypoventilation syndromes. J Clin Sleep Med. 2010 Oct 15;6(5):491-509.
Results Reference
result
PubMed Identifier
31368798
Citation
Mokhlesi B, Masa JF, Brozek JL, Gurubhagavatula I, Murphy PB, Piper AJ, Tulaimat A, Afshar M, Balachandran JS, Dweik RA, Grunstein RR, Hart N, Kaw R, Lorenzi-Filho G, Pamidi S, Patel BK, Patil SP, Pepin JL, Soghier I, Tamae Kakazu M, Teodorescu M. Evaluation and Management of Obesity Hypoventilation Syndrome. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2019 Aug 1;200(3):e6-e24. doi: 10.1164/rccm.201905-1071ST. Erratum In: Am J Respir Crit Care Med. 2019 Nov 15;200(10):1326.
Results Reference
result
PubMed Identifier
23103736
Citation
Carrillo A, Ferrer M, Gonzalez-Diaz G, Lopez-Martinez A, Llamas N, Alcazar M, Capilla L, Torres A. Noninvasive ventilation in acute hypercapnic respiratory failure caused by obesity hypoventilation syndrome and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1279-85. doi: 10.1164/rccm.201206-1101OC. Epub 2012 Oct 26.
Results Reference
result
PubMed Identifier
27852952
Citation
Howard ME, Piper AJ, Stevens B, Holland AE, Yee BJ, Dabscheck E, Mortimer D, Burge AT, Flunt D, Buchan C, Rautela L, Sheers N, Hillman D, Berlowitz DJ. A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity hypoventilation syndrome. Thorax. 2017 May;72(5):437-444. doi: 10.1136/thoraxjnl-2016-208559. Epub 2016 Nov 15.
Results Reference
result
PubMed Identifier
22382596
Citation
Murphy PB, Davidson C, Hind MD, Simonds A, Williams AJ, Hopkinson NS, Moxham J, Polkey M, Hart N. Volume targeted versus pressure support non-invasive ventilation in patients with super obesity and chronic respiratory failure: a randomised controlled trial. Thorax. 2012 Aug;67(8):727-34. doi: 10.1136/thoraxjnl-2011-201081. Epub 2012 Mar 1.
Results Reference
result
PubMed Identifier
26680503
Citation
Palm A, Midgren B, Janson C, Lindberg E. Gender differences in patients starting long-term home mechanical ventilation due to obesity hypoventilation syndrome. Respir Med. 2016 Jan;110:73-8. doi: 10.1016/j.rmed.2015.11.010. Epub 2015 Nov 26.
Results Reference
result
PubMed Identifier
17391112
Citation
Budweiser S, Riedl SG, Jorres RA, Heinemann F, Pfeifer M. Mortality and prognostic factors in patients with obesity-hypoventilation syndrome undergoing noninvasive ventilation. J Intern Med. 2007 Apr;261(4):375-83. doi: 10.1111/j.1365-2796.2007.01765.x.
Results Reference
result
PubMed Identifier
23341888
Citation
Borel JC, Burel B, Tamisier R, Dias-Domingos S, Baguet JP, Levy P, Pepin JL. Comorbidities and mortality in hypercapnic obese under domiciliary noninvasive ventilation. PLoS One. 2013;8(1):e52006. doi: 10.1371/journal.pone.0052006. Epub 2013 Jan 16.
Results Reference
result
PubMed Identifier
28958052
Citation
McArdle N, Rea C, King S, Maddison K, Ramanan D, Ketheeswaran S, Erikli L, Baker V, Armitstead J, Richards G, Singh B, Hillman D, Eastwood P. Treating Chronic Hypoventilation With Automatic Adjustable Versus Fixed EPAP Intelligent Volume-Assured Positive Airway Pressure Support (iVAPS): A Randomized Controlled Trial. Sleep. 2017 Oct 1;40(10). doi: 10.1093/sleep/zsx136.
Results Reference
result
Learn more about this trial
"Post-acute Pickwick Study" (Postacute-Pick-2020)
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