Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure
• Interventions: Device: Non Invasive Ventilation

• Registration Number: NCT01526642
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. 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 episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Primary Completion: 2013-12
• Study Completion: 2015-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Age > 18 years old
• COPD patients who survived after an episode of acute hypercapnic respiratory failure
• Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 > 55 mmHg and pH > 7.35

Exclusion Criteria

• Age > 85 years old
• Non- COPD causes of respiratory failure
• Obstructive sleep apnea excluded by polysomnography
• Adverse psychosocial status
• Serious co-morbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non Invasive Ventilation	Non Invasive Ventilation	-

Primary Outcome Measures

Name	Time	Method
Acute hypercapnic respiratory failure episode	up to 102 weeks

Secondary Outcome Measures

Name	Time	Method
Death	1 month and every 6 months during 2 years

Trial Locations

Locations (1)

CHU de Rouen; 🇫🇷 Rouen, France