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

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ClinicalTrials.gov Identifier: NCT03934749
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

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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.
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. 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


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

  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 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
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:

-


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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03934749     History of Changes
Other Study ID Numbers: 2018-A02135-50
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypercapnia
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms