Home Non Invasive Ventilation for COPD Patients

Not Applicable

Recruiting

• Conditions: Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease
• Interventions: Device: Home ventilator

• Registration Number: NCT03221101
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-12
• Status Verified: 2016-09
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-18
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• COPD patients who survived after an acute episode of hypercapnic respiratory failure
• patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH > 7.35 and PCO2 > = 45 mmHg

Exclusion Criteria

• severe obstructive sleep apnea ( DI > 30/h)
• Non COPD cause of respiratory failure
• Serious comorbidity
• Adverse psychological status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non invasive ventilation	Home ventilator	Home non invasive ventilation is prescribed with the following settings * PS mode * IPAP according to clinical and hemodynamic tolerance * EPAP according to air trapping * RR around 12/ min. * LOT for SaO2 \> 90% * Monitoring with capnometry for settings validation

Primary Outcome Measures

Name	Time	Method
acute hypercapnic respiratory failure episode	up to 24 months	first episode of acute hypercapnic respiratory failure episode requiring hospitalization

Secondary Outcome Measures

Name	Time	Method
acute hypercapnic respiratory failure episode rate	up to 24 months
pulmonary function test	at one month and every six months up to 24 months
Six Minute Walk Distance	at one month and every six months up to 24 months
Quality of life	at one month and every six months up to 24 months
Heart function	at one month and every six months up to 24 months	left and right heart function assessed using echocardiography
Cost effectiveness	at one month and every six months up to 24 months
mortality	at one month and every six months up to 24 months
arterial blood gas	at one month and every six months up to 24 months

Trial Locations

Locations (4)

CH Dieppe; 🇫🇷 Dieppe, France

CH Elbeuf; 🇫🇷 Elbeuf, France

Le Havre, Jacques Monod Hospital; 🇫🇷 Montivilliers, France

CHU de Rouen; 🇫🇷 Rouen, France