Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home

Recruiting

• Conditions: Respiratory Insufficiency

• Registration Number: NCT02346305
• Lead Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Brief Summary

The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases.

The investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment.

The main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• No previous experience with domiciliary non-invasive ventilation
• Adult patients, ≥ 18 years of age
• Without tracheotomy
• No evolutive cancer
• No significant psychiatric disease
• Possible medical monitoring

Exclusion Criteria

• Evolutive cancer
• Inability to understand rationale and/or consent form for study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical data leading to NIV device prescription	Day 1	Age, blood gases, BMI, etiology, pulmonary function,comorbidities

Secondary Outcome Measures

Name	Time	Method
Treatment compliance	1 year to 2 years (end of study)
Survival rate	2 years
Change in the possible comorbidities	4 months, 1 year and 2 years after inclusion
Change in blood gases	4 months, 1 year and 2 years after inclusion
Hospitalizations	2 years	During the study period all hospitalizations will be notify

Trial Locations

Locations (16)

CHU d'Angers; 🇫🇷 Angers, France

CH de Cannes; 🇫🇷 Cannes, France

CHU de Dijon; 🇫🇷 Dijon, France

Garches; 🇫🇷 Garches, France

CHU de Lille; 🇫🇷 Lille, France

AP-HP Pitié-Salpêtrière; 🇫🇷 Paris, France

CHU de Rouen; 🇫🇷 Rouen, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Besançon; 🇫🇷 Besançon, France

CHD de la Réunion; 🇫🇷 La Reunion, France

CHU de Limoges; 🇫🇷 Limoges, France

Hôpital Robert Schuman; 🇫🇷 Vantoux, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital Edouard Rist; 🇫🇷 Paris, France