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Continuous Positive Pressure Versus Bi-level in Overlap Syndrome

Primary Purpose

Overlap Syndrome, Nocturnal Hypoventilation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bi-level positive airway pressure with ventilatory support
continuous positive airway pressure without ventilatory support
Sponsored by
Hospital Sao Joao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overlap Syndrome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD (FEV1/FVC < 70 (post-BD) and history of smoking - 10 PPY)
  • FEV1< 80% and COPD symptoms
  • AHI ≥ 15 events/hour

Exclusion Criteria:

  • Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30 after bronchodilators)
  • Hypoxia requiring long term oxygen therapy
  • BMI > 35 kg/m2
  • Previously-initiated long term non-invasive positive pressure ventilation
  • Other lung disease resulting in respiratory symptoms
  • Age <40 years
  • Pregnancy
  • Malignant comorbidities
  • Patients undergoing renal replacement therapy
  • Restrictive lung disease causing hypercapnia
  • Severe heart failure, unstable angina and severe arrhythmias
  • Inability to comply with the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    CPAP

    Bi-level

    Arm Description

    Oronasal CPAP therapy applied as per current international guidelines

    Oronasal Bi-level therapy + supplemental oxygen (if necessary) applied as per current international guidelines

    Outcomes

    Primary Outcome Measures

    diurnal hypercapnia (pCO2 <= 45 mmH2O )
    (PaCO2 <= 45 mmH2O )
    nocturnal oxygen desaturation correction
    Mean nocturnal SpO2 >=90%, with <10% of the total recording time <90% after correction of leaks)

    Secondary Outcome Measures

    Changes in FEV1
    Forced Expiratory Volume (FEV1) in first second (% of predicted) from pre-intervention to follow up
    Changes in FVC
    Forced vital capacity (FVC) (% of predicted) from pre-intervention to follow up
    Changes in RV
    Residual volume (RV) (% of predicted) from pre-intervention to follow up
    exercise tolerance
    Change in the 6 minute walking test from pre-intervention to follow up
    Sleepiness evaluation
    Epworth sleepiness scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. Comparation of patient score from pre-intervention to follow up
    acute respiratory exacerbations
    Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission
    Compliance to PAP
    median hours of compliance per night
    PAP usage
    percentage of days of use per month
    Dyspnoea evaluation
    The mMRC Dyspnea Scale quantifies disability attributable to breathlessness and is useful for baseline dyspnea characterization in patients with respiratory diseases. The score can range from 0 to 4. The higher the mMRC score the higher the dyspnea. Comparation of patient score from pre-intervention to follow up
    Symptoms of COPD
    COPD Assessment test
    Apneia/Hiponeia Index
    Number of Residual AHI/per hour
    nocturnal hypoventilation
    ∆PtcCO2<10mmHg during night from pre-intervention to follow up

    Full Information

    First Posted
    February 8, 2017
    Last Updated
    December 5, 2018
    Sponsor
    Hospital Sao Joao
    Collaborators
    Marta Drummond MD PhD, Joao Carlos Winck MD PhD, Mafalda van Zeller MD Phstud
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03766542
    Brief Title
    Continuous Positive Pressure Versus Bi-level in Overlap Syndrome
    Official Title
    Optimal Positive Airway Pressure in Overlap Syndrome: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    July 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Sao Joao
    Collaborators
    Marta Drummond MD PhD, Joao Carlos Winck MD PhD, Mafalda van Zeller MD Phstud

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. When considering hypercapnic stable COPD patients, survival benefits occurred when the use of bi- level ventilation therapy was targeted to significantly reduce hypercapnia. This highlights the relevance of hypercapnia and hypoventilation correction. Thus, the purpose of this study is to compare the use of CPAP to Bi-level ventilation in hypercapnic OS patients, since the later may correct not only the airway patency but also increase the magnitude of each breath.
    Detailed Description
    Obstructive sleep apnea syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) represent two of the most prevalent respiratory disorders in clinical practice and their coexistence is often described has "overlap syndrome" (OS) In patients with COPD, the coexistence of OSA is associated with an increased risk of death from any cause, and hospitalization because of COPD exacerbation. Treatment with continuous positive airway pressure (CPAP) has been showed to be effective and associated with improved survival and decreased hospitalizations. When CPAP became established treatment for overlap syndrome, a multivariate analysis revealed that the hours of CPAP use were an independent predictor of mortality. Furthermore, it has been showed that the survival benefit of CPAP favors hypercapnic patients with overlap syndrome. Regarding hypercapnic stable COPD patients, the best results with long-term non-invasive positive pressure ventilation have been noted in studies using more intensive strategies of ventilation, with higher inspiratory pressures and higher backup rates that improved or even normalized daytime hypercapnia. In fact, survival benefits occurred when ventilation was targeted to significantly reduce hypercapnia. As for typical COPD, overlap syndrome patients might also benefit from optimal daytime hypercapnia correction, which could be better achieved using bi-level ventilation instead of CPAP, since it could not only maintain airway patency but also improve alveolar ventilation. This study aims to compare CPAP therapy to bi-level ventilatory support in overlap syndrome patients, not only for the efficacy to achieve hypercapnia reduction, but also regarding acute disease exacerbations, symptoms and treatment compliance. Therefore, the authors designed a randomized controlled trial with recruitment and power calculations based on the applicant's own data. After the diagnosis, patients will be randomized either for CPAP or BPAP treatment. If CPAP is to be initiated, optimal pressure to maintain upper airway patency will be determined. If there are continued obstructive respiratory events at 15 cm H2O of CPAP, patients will cross-over to the BPAP study arm. Regarding BPAP titration, patients will be treated with ventilators set in pressure support spontaneous/timed mode, both inspiratory and expiratory positive airway pressures (IPAP and EPAP) will be manually titrated. EPAP will ensure optimal pressure for maintaining upper airway patency and IPAP will be defined according to patient tolerance and pressure support necessary to achieve normal PaCO2 values or to reduce baseline PaCO2 by 20% or more; Follow-up will be performed at 1, 6 and 12 months. Follow-up will include clinical evaluation with physical examination and questionnaires (COPD Assessment test, Epworth Sleepiness Scale and MRC dyspnea score), blood gas analysis, treatment adherence, AHI, nocturnal pulse oximetry and exacerbations. 12-month follow-up will also include lung function test, 6-min walking test and nocturnal capnography.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overlap Syndrome, Nocturnal Hypoventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective randomized controlled trial.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CPAP
    Arm Type
    Active Comparator
    Arm Description
    Oronasal CPAP therapy applied as per current international guidelines
    Arm Title
    Bi-level
    Arm Type
    Experimental
    Arm Description
    Oronasal Bi-level therapy + supplemental oxygen (if necessary) applied as per current international guidelines
    Intervention Type
    Device
    Intervention Name(s)
    Bi-level positive airway pressure with ventilatory support
    Intervention Description
    Positive airway pressure will be applied in the experimental group through a oronasal interface, in ventilatory support mode (Bi-level) with a fixed backup rate.
    Intervention Type
    Device
    Intervention Name(s)
    continuous positive airway pressure without ventilatory support
    Intervention Description
    Continuous positive airway pressure (CPAP) will be applied in the active comparator group through a oronasal interface.
    Primary Outcome Measure Information:
    Title
    diurnal hypercapnia (pCO2 <= 45 mmH2O )
    Description
    (PaCO2 <= 45 mmH2O )
    Time Frame
    1 year
    Title
    nocturnal oxygen desaturation correction
    Description
    Mean nocturnal SpO2 >=90%, with <10% of the total recording time <90% after correction of leaks)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Changes in FEV1
    Description
    Forced Expiratory Volume (FEV1) in first second (% of predicted) from pre-intervention to follow up
    Time Frame
    1 year
    Title
    Changes in FVC
    Description
    Forced vital capacity (FVC) (% of predicted) from pre-intervention to follow up
    Time Frame
    1 year
    Title
    Changes in RV
    Description
    Residual volume (RV) (% of predicted) from pre-intervention to follow up
    Time Frame
    1 year
    Title
    exercise tolerance
    Description
    Change in the 6 minute walking test from pre-intervention to follow up
    Time Frame
    1 year
    Title
    Sleepiness evaluation
    Description
    Epworth sleepiness scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. Comparation of patient score from pre-intervention to follow up
    Time Frame
    1 year
    Title
    acute respiratory exacerbations
    Description
    Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission
    Time Frame
    1 year
    Title
    Compliance to PAP
    Description
    median hours of compliance per night
    Time Frame
    1 year
    Title
    PAP usage
    Description
    percentage of days of use per month
    Time Frame
    1 year
    Title
    Dyspnoea evaluation
    Description
    The mMRC Dyspnea Scale quantifies disability attributable to breathlessness and is useful for baseline dyspnea characterization in patients with respiratory diseases. The score can range from 0 to 4. The higher the mMRC score the higher the dyspnea. Comparation of patient score from pre-intervention to follow up
    Time Frame
    1 year
    Title
    Symptoms of COPD
    Description
    COPD Assessment test
    Time Frame
    1 year
    Title
    Apneia/Hiponeia Index
    Description
    Number of Residual AHI/per hour
    Time Frame
    1 year
    Title
    nocturnal hypoventilation
    Description
    ∆PtcCO2<10mmHg during night from pre-intervention to follow up
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: COPD (FEV1/FVC < 70 (post-BD) and history of smoking - 10 PPY) FEV1< 80% and COPD symptoms AHI ≥ 15 events/hour Exclusion Criteria: Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30 after bronchodilators) Hypoxia requiring long term oxygen therapy BMI > 35 kg/m2 Previously-initiated long term non-invasive positive pressure ventilation Other lung disease resulting in respiratory symptoms Age <40 years Pregnancy Malignant comorbidities Patients undergoing renal replacement therapy Restrictive lung disease causing hypercapnia Severe heart failure, unstable angina and severe arrhythmias Inability to comply with the protocol

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Continuous Positive Pressure Versus Bi-level in Overlap Syndrome

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