Home Non Invasive Ventilation for COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— NIVOLD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221101
• Other study ID #: 2013-AO1276-39 2010/080/HP
• Secondary ID: CPP-SC 010/2013
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: July 19, 2017
• Start date: December 2011
• Est. completion date: December 2025

Study information

• Verified date: September 2016
• Source: University Hospital, Rouen
• Contact: Bouchra Lamia, MD, MPH, PhD
• Phone: 0685426884
• Email: bouchra.lamia[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2025
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Hypercapnic Respiratory Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Device:
• Home ventilator

Locations

Country	Name	City	State
France	CH Dieppe	Dieppe
France	CH Elbeuf	Elbeuf
France	Le Havre, Jacques Monod Hospital	Montivilliers
France	CHU de Rouen	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute hypercapnic respiratory failure episode	first episode of acute hypercapnic respiratory failure episode requiring hospitalization	up to 24 months
Secondary	acute hypercapnic respiratory failure episode rate		up to 24 months
Secondary	pulmonary function test		at one month and every six months up to 24 months
Secondary	Six Minute Walk Distance		at one month and every six months up to 24 months
Secondary	Quality of life		at one month and every six months up to 24 months
Secondary	Heart function	left and right heart function assessed using echocardiography	at one month and every six months up to 24 months
Secondary	Cost effectiveness		at one month and every six months up to 24 months
Secondary	mortality		at one month and every six months up to 24 months
Secondary	arterial blood gas		at one month and every six months up to 24 months