Home Non Invasive Ventilation for COPD Patients

NCT03221101 | Unknown DMC

• 2 other identifiers: 2013-AO1276-39 2010/080/HPCPP-SC 010/2013
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• acute hypercapnic respiratory failure episode

  first episode of acute hypercapnic respiratory failure episode requiring hospitalization

  up to 24 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Long Term Oxygen Therapy alone

NO INTERVENTION

Long Term oxygen therapy is prescribed according to the guidelines

Non invasive ventilation

ACTIVE COMPARATOR

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

Device: Home ventilator

Interventions

Home ventilator DEVICE

Non invasive ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• ADIR Association: collaborator

Study Sites (4)

CH Dieppe

Dieppe, France

RECRUITING

CH Elbeuf

Elbeuf, France

RECRUITING

Le Havre, Jacques Monod Hospital

Montivilliers, 76290, France

RECRUITING

CHU de Rouen

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Central Study Contacts

Bouchra Lamia, MD, MPH, PhD

CONTACT

0685426884; bouchra.lamia@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medecine, pulmonology. MD, MPH, PhD

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2025
• Last Updated: July 21, 2017

Record last verified: 2016-09

Locations

FR (4)