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

March 28, 2023 updated by: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

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.

Study Overview

Status

Recruiting

Conditions

Respiratory Insufficiency

Intervention / Treatment

Device: Non-invasive ventilation

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Didier FORET
Phone Number: 33 (1) 56 81 40 60
Email: antadir@antadir.com

Study Locations

France
- - Angers, France
    - Not yet recruiting
    - CHU d'Angers
    - Contact:
      
      Frédéric GAGNADOUX, Pr
  - Besançon, France
    - Not yet recruiting
    - CHU de Besançon
    - Contact:
      
      Frédéric CLAUDE, MD
  - Cannes, France
    - Not yet recruiting
    - CH de Cannes
  - Dijon, France
    - Recruiting
    - CHU de Dijon
    - Contact:
      
      Claudio RABEC, MD
      
      Email: claudio.rabec@chu-dijon.fr
  - Garches, France
    - Not yet recruiting
    - Garches
    - Contact:
      
      Hélène PRIGENT, MD
  - Grenoble, France
    - Not yet recruiting
    - CHU de GRENOBLE
    - Contact:
      
      Jean-Louis Pépin, Pr
  - La Reunion, France
    - Not yet recruiting
    - CHD de la Réunion
    - Contact:
      
      Ziad RIDA, MD
  - Lille, France
    - Not yet recruiting
    - CHU de Lille
  - Limoges, France
    - Not yet recruiting
    - CHU de Limoges
    - Contact:
      
      Boris MELLONI, Pr
  - Nancy, France
    - Not yet recruiting
    - CHU de Nancy
    - Contact:
      
      François CHABOT, Pr
  - Paris, France
    - Not yet recruiting
    - Ap-Hp Pitie-Salpetriere
    - Contact:
      
      Jésus GONZALEZ, MD
  - Paris, France
    - Not yet recruiting
    - Hôpital Edouard Rist
    - Contact:
      
      Franck LAVERGNE, MD
  - Rouen, France
    - Recruiting
    - CHU de Rouen
    - Contact:
      
      Antoine CUVELIER, Pr
  - Rouen, France
    - Not yet recruiting
    - CHU de Rouen
    - Contact:
      
      Jean-François MUIR, Pr
  - Strasbourg, France
    - Not yet recruiting
    - CHU de Strasbourg
    - Contact:
      
      Romain KESSLER, Pr
  - Toulouse, France
    - Not yet recruiting
    - CHU de Toulouse
    - Contact:
      
      Sandrine PONTIER, MD
  - Vantoux, France
    - Not yet recruiting
    - Hôpital Robert Schuman
    - Contact:
      
      Pierre CERVANTES, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with respiratoy insufficiency

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical data leading to NIV device prescription Time Frame: Day 1	Age, blood gases, BMI, etiology, pulmonary function,comorbidities	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Investigators

Principal Investigator: Claudio RABEC, MD, Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

2014 - NIV - 14734

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.