Non-invasive Home Ventilation in Patients With Severe Hypercapnic Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— SOMNOVENT'  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03934749
• Other study ID #: 2018-A02135-50
• Status: Terminated
• Start date: June 27, 2019
• Est. completion date: September 27, 2020

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 27, 2020
• Est. primary completion date: June 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD using Gold 2017 criterion

• Optimal medical treatment of COPD, ie. inhaled steroids, long-acting ß2-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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Non Invasive Ventilation
NIV using standard mode or Lowenstein mode

Locations

Country	Name	City	State
France	CHRU Jean Minjoz	Besançon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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