Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home
Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home
1 other identifier
observational
3,000
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 29, 2023
March 1, 2023
9.9 years
January 9, 2015
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical data leading to NIV device prescription
Age, blood gases, BMI, etiology, pulmonary function,comorbidities
Day 1
Secondary Outcomes (11)
Change in blood gases
4 months, 1 year and 2 years after inclusion
Change in the possible comorbidities
4 months, 1 year and 2 years after inclusion
Treatment compliance
Initiation of treatment to 4 months
Treatment compliance
4 months to 1 year
Treatment compliance
1 year to 2 years (end of study)
- +6 more secondary outcomes
Interventions
Home NIV installation
Eligibility Criteria
Patients with respiratoy insufficiency
You may qualify if:
- 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
You may not qualify if:
- Evolutive cancer
- Inability to understand rationale and/or consent form for study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CHU d'Angers
Angers, France
CHU de Besançon
Besançon, France
CH de Cannes
Cannes, France
CHU de Dijon
Dijon, France
Garches
Garches, France
CHU de Grenoble
Grenoble, France
CHD de la Réunion
La Réunion, France
CHU de Lille
Lille, France
CHU de Limoges
Limoges, France
CHU de Nancy
Nancy, France
AP-HP Pitié-Salpêtrière
Paris, France
Hôpital Edouard Rist
Paris, France
CHU de Rouen
Rouen, France
CHU de Rouen
Rouen, France
CHU de Strasbourg
Strasbourg, France
CHU de Toulouse
Toulouse, France
Hôpital Robert Schuman
Vantoux, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio RABEC, MD
Centre Hospitalier Universitaire Dijon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 27, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 29, 2023
Record last verified: 2023-03