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出境医 / 临床实验 / Non-invasive Home Ventilation in Patients With Severe Hypercapnic Chronic Obstructive Pulmonary Disease (SOMNOVENT')

Non-invasive Home Ventilation in Patients With Severe Hypercapnic Chronic Obstructive Pulmonary Disease (SOMNOVENT')

Study Description
Brief Summary:

In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known.

In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation.

The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Hypercapnia Device: Non Invasive Ventilation

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep.
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
Group/Cohort Intervention/treatment
standard mode
after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV using Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.
Device: Non Invasive Ventilation
NIV using standard mode or Lowenstein mode

Lowenstein mode
after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV without Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.
Device: Non Invasive Ventilation
NIV using standard mode or Lowenstein mode

Outcome Measures
Primary Outcome Measures :
  1. Mean carbon dioxide partial pressure-level during non invasive ventilation [ Time Frame: 2 nights ]
    Mean pCO2 level over night calculated using transcutaneous measurement of partial pressure of carbon dioxide under non invasive ventilation. Device : transcutaneous capnography (PtcCO2); SenTec Digital Monitoring System


Secondary Outcome Measures :
  1. Number of respiratory events during non invasive ventilation [ Time Frame: 2 nights ]
    According to consensus group, nocturnal respiratory events are : unintentional leak, obstruction at different levels of the upper airways and asynchrony (ineffective effort, auto-triggering, and double triggering, premature or delayed cycling)

  2. Sleep quality [ Time Frame: 2 nights ]
    Changes in data of polysomnography (total sleep time (TST) ; total recording time ; sleep latency, sleep efficiency (TST/time in bed) ; time in each stages plus percent of TST in each stage ; stage REM latency ; wake time after sleep onset ; arousal index)

  3. Ventilation quality [ Time Frame: 2 nights ]
    Subjective changes in quality of ventilator by specific auto questionnaire (quality of night, feeling, dyspnea, quality of ventilation, respiratory disturbance caused by NIV, sleep disturbance caused by NIV). The patient answers to each question using a "likert scale" in terms of intensity. The second questionnaire is the S3-NIV which is a tool for the routine clinical assessment of patients undergoing home NIV.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed in the pneumology department of the Besançon university hospital.
Criteria

Inclusion Criteria:

  • Diagnosis of COPD using Gold 2017 criterion
  • Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist, long-acting anticholinergic, according to GOLD 2017 guidelines.
  • At least one acute exacerbation of COPD with hypercapnic respiratory failure
  • Introduction of NIV distant to acute exacerbation of COPD with persisting hypercapnia (> 7kPa) on arterial blood gas at rest.
  • NIV equipment from the service provider "Don Du Souffle (DDS)".
  • Patient able to give their consent

Exclusion Criteria:

  • Contraindication to NIV (consensus conference of SFAR-SPLF-SRLF)
  • Obstructive sleep apnea with apnea/hypopnea index > to 20/h
  • BMI > 35 kg/m2
  • Low compliance with NIV treatment (<3h per day)
  • Acute exacerbation COPD during inclusion or pH <7.30 in routine blood gas arterial
  • Severe heart failure (New York Heart Association stage IV/IV)
  • Unstable angina
  • Severe arrhythmias
  • Severe renal insufficiency stage > 4
  • Other conditions than COPD resulting in hypercapnia
  • Pregnancy
  • Patient without health insurance
  • Patient excluded by another study
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Frédéric Claudé 0381669293 fclaude@chu-besancon.fr
Contact: Lucie Laurent 0381669293 llaurent@chu-besancon.fr

Locations
Layout table for location information
France
CHRU Jean Minjoz Recruiting
Besançon, Doubs, France, 25000
Contact: Frédéric Claude       fclaude@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Tracking Information
First Submitted Date April 29, 2019
First Posted Date May 2, 2019
Last Update Posted Date April 6, 2020
Actual Study Start Date June 27, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2020)
Mean carbon dioxide partial pressure-level during non invasive ventilation [ Time Frame: 2 nights ]
Mean pCO2 level over night calculated using transcutaneous measurement of partial pressure of carbon dioxide under non invasive ventilation. Device : transcutaneous capnography (PtcCO2); SenTec Digital Monitoring System
Original Primary Outcome Measures
 (submitted: April 29, 2019)
Mean Arterial carbon dioxide partial pressure-level during non invasive ventilation [ Time Frame: 2 nights ]
Mean pCO2 level over night calculated using transcutaneous measurement of partial pressure of carbon dioxide under non invasive ventilation. Device : transcutaneous capnography (PtcCO2) SenTec Digital Monitoring System
Change History
Current Secondary Outcome Measures
 (submitted: April 2, 2020)
  • Number of respiratory events during non invasive ventilation [ Time Frame: 2 nights ]
    According to consensus group, nocturnal respiratory events are : unintentional leak, obstruction at different levels of the upper airways and asynchrony (ineffective effort, auto-triggering, and double triggering, premature or delayed cycling)
  • Sleep quality [ Time Frame: 2 nights ]
    Changes in data of polysomnography (total sleep time (TST) ; total recording time ; sleep latency, sleep efficiency (TST/time in bed) ; time in each stages plus percent of TST in each stage ; stage REM latency ; wake time after sleep onset ; arousal index)
  • Ventilation quality [ Time Frame: 2 nights ]
    Subjective changes in quality of ventilator by specific auto questionnaire (quality of night, feeling, dyspnea, quality of ventilation, respiratory disturbance caused by NIV, sleep disturbance caused by NIV). The patient answers to each question using a "likert scale" in terms of intensity. The second questionnaire is the S3-NIV which is a tool for the routine clinical assessment of patients undergoing home NIV.
Original Secondary Outcome Measures
 (submitted: April 29, 2019)
  • Number of respiratory events during non invasive ventilation [ Time Frame: 2 nights ]
    According to consensus group, nocturnal respiratory events are : unintentional leak, obstruction at different levels of the upper airways and asynchrony (ineffective effort, auto-triggering, and double triggering, premature or delayed cycling)
  • Sleep quality [ Time Frame: 2 nights ]
    Changes in data of polysomnography
  • Ventilation quality [ Time Frame: 2 nights ]
    Subjective changes in quality of ventilator by specific auto questionnaire (quality of night, feeling, dyspnea, quality of ventilation, respiratory disturbance caused by NIV, sleep disturbance caused by NIV). The patient answers to each question using a "likert scale" in terms of intensity. The second questionnaire is the S3-NIV which is a tool for the routine clinical assessment of patients undergoing home NIV.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-invasive Home Ventilation in Patients With Severe Hypercapnic Chronic Obstructive Pulmonary Disease
Official Title Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep.
Brief Summary

In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known.

In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation.

The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients followed in the pneumology department of the Besançon university hospital.
Condition
  • Chronic Obstructive Pulmonary Disease
  • Hypercapnia
Intervention Device: Non Invasive Ventilation
NIV using standard mode or Lowenstein mode
Study Groups/Cohorts
  • standard mode
    after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV using Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.
    Intervention: Device: Non Invasive Ventilation
  • Lowenstein mode
    after adjusting pressure and different modes of ventilation to each individual patient. Each one of them will receive NIV without Löwenstein mode during one night at home. Patients will be under transcutaneous PCO2 measurement and polysomnographic surveillance.
    Intervention: Device: Non Invasive Ventilation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 29, 2019)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of COPD using Gold 2017 criterion
  • Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist, long-acting anticholinergic, according to GOLD 2017 guidelines.
  • At least one acute exacerbation of COPD with hypercapnic respiratory failure
  • Introduction of NIV distant to acute exacerbation of COPD with persisting hypercapnia (> 7kPa) on arterial blood gas at rest.
  • NIV equipment from the service provider "Don Du Souffle (DDS)".
  • Patient able to give their consent

Exclusion Criteria:

  • Contraindication to NIV (consensus conference of SFAR-SPLF-SRLF)
  • Obstructive sleep apnea with apnea/hypopnea index > to 20/h
  • BMI > 35 kg/m2
  • Low compliance with NIV treatment (<3h per day)
  • Acute exacerbation COPD during inclusion or pH <7.30 in routine blood gas arterial
  • Severe heart failure (New York Heart Association stage IV/IV)
  • Unstable angina
  • Severe arrhythmias
  • Severe renal insufficiency stage > 4
  • Other conditions than COPD resulting in hypercapnia
  • Pregnancy
  • Patient without health insurance
  • Patient excluded by another study
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934749
Other Study ID Numbers 2018-A02135-50
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date April 2019