Clinical trial NCT02346305: Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home
Official title: Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Insufficiency
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with respiratoy insufficiency

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical data leading to NIV device prescription
timeFrame: Day 1
Secondary outcomes:
measure: Change in blood gases
timeFrame: 4 months, 1 year and 2 years after inclusion
measure: Change in the possible comorbidities
timeFrame: 4 months, 1 year and 2 years after inclusion
measure: Treatment compliance
timeFrame: Initiation of treatment to 4 months
measure: Treatment compliance
timeFrame: 4 months to 1 year
measure: Treatment compliance
timeFrame: 1 year to 2 years (end of study)
measure: Hospitalizations
timeFrame: 4 months
measure: Hospitalizations
timeFrame: 1 year
measure: Hospitalizations
timeFrame: 2 years
measure: Survival rate
timeFrame: 4 months
measure: Survival rate
timeFrame: 1 year
measure: Survival rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Besançon
country: France
facility: CHU de Besançon
city: Cannes
country: France
facility: CH de Cannes
city: Dijon
country: France
facility: CHU de Dijon
city: Garches
country: France
facility: Garches
city: Grenoble
country: France
facility: CHU de Grenoble
city: La Reunion
country: France
facility: CHD de la Réunion
city: Lille
country: France
facility: CHU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Nancy
country: France
facility: CHU de Nancy
city: Paris
country: France
facility: AP-HP Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Edouard Rist
city: Rouen
country: France
facility: CHU de Rouen
city: Rouen
country: France
facility: CHU de Rouen
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Vantoux
country: France
facility: Hôpital Robert Schuman
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Claudio RABEC, MD
role: PRINCIPAL_INVESTIGATOR
References: