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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH Dieppe
RECRUITING
Dieppe
CH Elbeuf
RECRUITING
Elbeuf
Le Havre, Jacques Monod Hospital
RECRUITING
Montivilliers
CHU de Rouen
RECRUITING
Rouen
Contact Information
Primary
Bouchra Lamia, MD, MPH, PhD
bouchra.lamia@chu-rouen.fr
0685426884
Time Frame
Start Date: 2011-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 86
Treatments
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
Sponsors
Collaborators: ADIR Association
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov