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

Intervention / Treatment

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

Study Locations

  • France
      • Angers, France
        • Not yet recruiting
        • CHU d'Angers
        • Contact:
          • Frédéric GAGNADOUX, Pr
      • Besançon, France
        • Not yet recruiting
        • CHU de Besancon
        • Contact:
          • Frédéric CLAUDE, MD
      • Cannes, France
        • Not yet recruiting
        • CH de Cannes
      • Dijon, France
      • Garches, France
        • Not yet recruiting
        • Garches
        • Contact:
          • Hélène PRIGENT, MD
      • Grenoble, France
        • Not yet recruiting
        • Chu de Grenoble
        • Contact:
          • Jean-Louis PEPIN, 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

No

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.

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