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

Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep.

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnia
• Intervention / Treatment: Device: Non Invasive Ventilation

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Doubs
    • Besançon, Doubs, France, 25000
      • CHRU Jean Minjoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients followed in the pneumology department of the Besançon university hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean carbon dioxide partial pressure-level during non invasive ventilation	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	2 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of respiratory events during non invasive ventilation	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 nights
Sleep quality	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)	2 nights
Ventilation quality	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.	2 nights

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): June 27, 2020
• Study Completion (Actual): September 27, 2020

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypercapnia
• Other Study ID Numbers: 2018-A02135-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No