Respiratory Insufficiency Clinical Trial
Official title:
Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home
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.
| Status | Recruiting |
| Enrollment | 3000 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 Reunion | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical data leading to NIV device prescription | Age, blood gases, BMI, etiology, pulmonary function,comorbidities | Day 1 | |
| Secondary | Change in blood gases | 4 months, 1 year and 2 years after inclusion | ||
| Secondary | Change in the possible comorbidities | 4 months, 1 year and 2 years after inclusion | ||
| Secondary | Treatment compliance | Initiation of treatment to 4 months | ||
| Secondary | Treatment compliance | 4 months to 1 year | ||
| Secondary | Treatment compliance | 1 year to 2 years (end of study) | ||
| Secondary | Hospitalizations | During the study period all hospitalizations will be notify | 4 months | |
| Secondary | Hospitalizations | During the study period all hospitalizations will be notify | 1 year | |
| Secondary | Hospitalizations | During the study period all hospitalizations will be notify | 2 years | |
| Secondary | Survival rate | 4 months | ||
| Secondary | Survival rate | 1 year | ||
| Secondary | Survival rate | 2 years |
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