Back to resultsSleep Ventilation for Patients With Advanced Hypercapnic COPD
Primary Purpose
COPD
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.
Arterial blood gas (ABG) and serum bicarbonate level
Overnight home oximetry and transcutaneous CO2 monitoring
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure.
Male or female aged ≥ 18 years with advanced hypercapnic COPD
- FEV1 ≤ 50% predicted and
- Prolonged hypercapnia during the daytime, at rest, without O2 or ventilatory support, PaCO2 > 52 mmHg on ABG (performed off of NIPPV), compensated with pH > 7.30
- Willingness to use NIPPV treatment
- English speaking
Women and minorities will be recruited in numbers reflecting representation in the Boston Metropolitan community which is approximately 84% Caucasian, 9% African American, 5% Hispanic American, and 2% Asian American, as the knowledge gained can apply to individuals of all ethnic background and gender.
We do not wish to limit our sample to a highly selected group of patients, to allow for more generalizable results.
Exclusion Criteria:
Subjects will be excluded from participation in the study for a history of:
- Significant sleep disordered breathing (AHI 4% ≥ 15 events/hour) or high clinical suspicion (BMI ≥ 35)
- Neuromuscular disease or other causes of hypoventilation
- Abnormalities of the thorax or lungs other than COPD
- Already treated with home NIPPV
- Unable to wean from ventilator during admission
- Unable to wean from NIPPV, pH < 7.30
- Recent tracheotomy decannulation
- History of severe depression or bipolar disorder requiring prior hospitalization or suicide attempts or ideation
- Cognitive impairment (such as advanced dementia) that would limit ability to provide consent or to use NIPPV
- Active recreational drug use
- Unstable housing that would limit ability to use NIPPV
- Severe heart failure (New York Heart Association stage IV)
- Active/unstable CAD
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Usual care
Usual care plus NIPPV group only
Arm Description
Usual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Usual care for COPD based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines plus use of nocturnal ventilator device using the Breas VIVO 50 home ventilator, Breas Medical (or any newer models as available).
Outcomes
Primary Outcome Measures
Time to readmission or death
time to re-admission for acute exacerbation of COPD and/or acute on chronic hypercapnic respiratory failure or death
Secondary Outcome Measures
Patient health related quality of life (HRQOL)
The RAND SF-36, a 36-question multiple choice QOL form will be used to assess general health perception. The questions target eight health domains or scales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal/emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and one's perceived change in health.
There is a 2-step process used in scoring, such that the score for each of the scales represent the average for all item in the scale that were answered. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Next, items in the same scale are averaged together to create 8 scale scores. The lower the score the more disability and the higher the score the less disability.
Scores will be assessed at baseline, 3 and 12 months for usual care and usual care plus ventilation support for all subjects.
Dyspnea scale
change in results of the Medical Research Council dyspnea scale, a categorical scale from 1-5, higher score =more limitation on daily activity due to breathlessness. Scores will be assessed at baseline, 3 and 12 months for usual care and usual care plus ventilation subjects.
Gas exchange
Change in CO2 from ABG and serum bicarbonate
General health status
St. George's Respiratory questionnaire, a 50 item questionnaire that measures health status in patients with COPD will be completed at baseline, and after 3 and 12 months in all subjects. For this questionnaire, a score of 0 = best QOL, and a score of 100 = worst QOL. The questions focus on three areas - symptoms, activity, and impact (psycho-social).
Full Information
NCT ID
NCT04210050
First Posted
December 17, 2019
Last Updated
January 3, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Breas Medical S.A.R.L.
1. Study Identification
Unique Protocol Identification Number
NCT04210050
Brief Title
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
Official Title
Implementation of a Precision Sleep Ventilation (PSV) Chronic Respiratory Failure Management Program for Patients With Advanced Hypercapnic COPD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Trial was not initiated due to COVID19 pandemic
Study Start Date
September 30, 2020 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Breas Medical S.A.R.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking.
The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.
Detailed Description
The purpose of this protocol is to perform a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure. The study will focus on the primary end-points of time to hospital re-admission for acute exacerbation of COPD and/or an episode of acute on chronic hypercapnic respiratory failure, in addition to other clinically relevant outcomes including patient health-related quality of life, sleep quality indices, and gas exchange parameters. Approximately 300 BIDMC adult patients will be recruited and each patient monitored over a period of 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The model is a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Arm Title
Usual care plus NIPPV group only
Arm Type
Active Comparator
Arm Description
Usual care for COPD based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines plus use of nocturnal ventilator device using the Breas VIVO 50 home ventilator, Breas Medical (or any newer models as available).
Intervention Type
Device
Intervention Name(s)
Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.
Intervention Description
In the usual care plus NIPPV group, those able to undergo attended PSG will be titrated with volume targeted pressure support mode, aiming to lower the baseline TcCO2 by 10 mmHg. In some cases, the CO2 cannot be lowered by that amount on a single titration, but rather will decrease over time.
For those unable to undergo lab titration (too frail, no transportation, decline/refuse), NIPPV will be initiated with empiric settings based on nighttime home CO2 tracking and daytime ABG monitoring.
Intervention Type
Diagnostic Test
Intervention Name(s)
Arterial blood gas (ABG) and serum bicarbonate level
Intervention Description
Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study
Intervention Type
Diagnostic Test
Intervention Name(s)
Overnight home oximetry and transcutaneous CO2 monitoring
Intervention Description
will be conducted at 1 and 6 months into the study (for subjects in the NIPPV plus usual care group, testing will be done while using the ventilator.
Primary Outcome Measure Information:
Title
Time to readmission or death
Description
time to re-admission for acute exacerbation of COPD and/or acute on chronic hypercapnic respiratory failure or death
Time Frame
within 12 months
Secondary Outcome Measure Information:
Title
Patient health related quality of life (HRQOL)
Description
The RAND SF-36, a 36-question multiple choice QOL form will be used to assess general health perception. The questions target eight health domains or scales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal/emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and one's perceived change in health.
There is a 2-step process used in scoring, such that the score for each of the scales represent the average for all item in the scale that were answered. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Next, items in the same scale are averaged together to create 8 scale scores. The lower the score the more disability and the higher the score the less disability.
Scores will be assessed at baseline, 3 and 12 months for usual care and usual care plus ventilation support for all subjects.
Time Frame
12 months
Title
Dyspnea scale
Description
change in results of the Medical Research Council dyspnea scale, a categorical scale from 1-5, higher score =more limitation on daily activity due to breathlessness. Scores will be assessed at baseline, 3 and 12 months for usual care and usual care plus ventilation subjects.
Time Frame
12 months
Title
Gas exchange
Description
Change in CO2 from ABG and serum bicarbonate
Time Frame
12 months
Title
General health status
Description
St. George's Respiratory questionnaire, a 50 item questionnaire that measures health status in patients with COPD will be completed at baseline, and after 3 and 12 months in all subjects. For this questionnaire, a score of 0 = best QOL, and a score of 100 = worst QOL. The questions focus on three areas - symptoms, activity, and impact (psycho-social).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Ambulatory BP profiles
Description
In a subset of subjects (from usual care and usual care plus ventilation groups), 24-hour ambulatory BP monitoring will be conducted (at baseline and after 3 months) to assess for change in 24-hour and nocturnal systolic, diastolic and mean BPs.
Time Frame
3 months compared to baseline
Title
Inflammatory biomarkers
Description
High sensitivity C-reactive protein [hs-CRP], units mg/ml, can be measured from peripheral blood. Elevated levels reflect increased systemic inflammation. Studies have shown that individuals with elevated levels (above 2 mg/ml) are at increased risk of cardiovascular disease. During this trial, HR-CRP will be obtained at baseline and after 3 and 12 months in subjects to assess whether there is a favorable change in subjects treated with nocturnal ventilation + usual care, as compared to usual care.
Time Frame
3 and 12 months compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent prior to any study-mandated procedure.
Male or female aged ≥ 18 years with advanced hypercapnic COPD
FEV1 ≤ 50% predicted and
Prolonged hypercapnia during the daytime, at rest, without O2 or ventilatory support, PaCO2 > 52 mmHg on ABG (performed off of NIPPV), compensated with pH > 7.30
Willingness to use NIPPV treatment
English speaking
Women and minorities will be recruited in numbers reflecting representation in the Boston Metropolitan community which is approximately 84% Caucasian, 9% African American, 5% Hispanic American, and 2% Asian American, as the knowledge gained can apply to individuals of all ethnic background and gender.
We do not wish to limit our sample to a highly selected group of patients, to allow for more generalizable results.
Exclusion Criteria:
Subjects will be excluded from participation in the study for a history of:
Significant sleep disordered breathing (AHI 4% ≥ 15 events/hour) or high clinical suspicion (BMI ≥ 35)
Neuromuscular disease or other causes of hypoventilation
Abnormalities of the thorax or lungs other than COPD
Already treated with home NIPPV
Unable to wean from ventilator during admission
Unable to wean from NIPPV, pH < 7.30
Recent tracheotomy decannulation
History of severe depression or bipolar disorder requiring prior hospitalization or suicide attempts or ideation
Cognitive impairment (such as advanced dementia) that would limit ability to provide consent or to use NIPPV
Active recreational drug use
Unstable housing that would limit ability to use NIPPV
Severe heart failure (New York Heart Association stage IV)
Active/unstable CAD
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Subject information and biological samples will be used and shared with the researchers involved in this study to conduct the research.
Learn more about this trial
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
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