Home Non Invasive Ventilation for COPD Patients (NIVOLD)

Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: Home ventilator

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bouchra Lamia, MD, MPH, PhD; Phone Number: 33 0685426884; Email: bouchra.lamia@chu-rouen.fr

Study Locations

• France
  • Dieppe, France
    • Recruiting
    • CH Dieppe
    • Contact: Pierre Louis Declercq, MD
  • Elbeuf, France
    • Recruiting
    • CH Elbeuf
    • Contact: Mahdi Ould, MD
  • Montivilliers, France, 76290
    • Recruiting
    • Le Havre, Jacques Monod Hospital
    • Contact: Clement Medrinal; Phone Number: +33664615110; Email: medrinal.clement.mk@gmail.com
  • Rouen, France, 76000
    • Recruiting
    • CHU de Rouen
    • Contact: Bouchra Lamia, MD, MPH, PhD; Phone Number: 0033 02 32 88 90 84; Email: bouchra.lamia@chu-rouen.fr
    • Principal Investigator: Bouchra Lamia, MD, MPH, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Long Term Oxygen Therapy alone; Long Term oxygen therapy is prescribed according to the guidelines
Active Comparator: Non invasive ventilation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute hypercapnic respiratory failure episode	first episode of acute hypercapnic respiratory failure episode requiring hospitalization	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	left and right heart function assessed using echocardiography	at one month and every six months up to 24 months
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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: ADIR Association

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: 2013-AO1276-39 2010/080/HP; CPP-SC 010/2013 (Other Identifier: Rouen University, Normandy France)

Drug and device information, study documents

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