Non Invasive Ventilation and Weaning : VENISE Trial (VENISE)

April 13, 2026 updated by: University Hospital, Rouen

Randomized Prospective Multicenter Study of Non Invasive Ventilation Assessment for Weaning From Mechanical Ventilation in Patients With Chronic Respiratory Failure. NIV and Weaning (VENISE)Trial.

The clinical efficacy of noninvasive ventilation (NIV) has now been demonstrated in the management of acute-on-chronic respiratory failure (ACRF) of various etiologies. Endotracheal mechanical ventilation (ETMV) can lead to numerous complications and weaning difficulties increasing the risk of prolonged ETMV, morbidity and mortality as well as excess cost of intensive care. Therefore, it could be interesting to use NIV for delivering effective ventilatory support and reduce the length of ETMV in ACRF patients still not capable to maintain spontaneous breathing. From the interesting but discordant results of two recent randomised controlled trial, a working group from the Société de Réanimation de Langue Française (SRLF) decided to perform a new prospective randomised controlled and multicenter trial. The aim of the study is to assess the usefulness of NIV as an extubation and weaning technique in ventilated ACRF patients. The methodology used compares three weaning strategies in parallel in ACRF patients considered difficult to wean : invasive conventional weaning (group A), extubation relayed by nasal oxygentherapy (group B), and extubation relayed by NIV (group C). Based on the main end-point defined as the weaning success/failure rate, 208 patients from17 investigator centers are planned to be included. Results of the study will also allow to assess the respective impact of the three weaning strategies on the length of ETMV and weaning, the mechanical ventilation-related morbidity, the patients lengths of stay and mortality.

Results of the VENISE trial should permit to improve the management of the difficult to wean ACRF patients and thus to contribute to more define the place of NIV among the weaning and prevention of re-intubation strategies in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

205

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Rouen, France, 76031
        • Rouen University Charles Nicolle Hospital

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

Description

Inclusion Criteria:

  • endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure in chronic respiratory failure patients (obstructive or restrictive disease),
  • patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
  • spontaneous breathing trial failure occurring between 5 minutes and 2 hours, judged on clinical and/or arterial blood gas tolerance,
  • written informed consent obtained (patient or family)

Exclusion Criteria:

  • respiratory and hemodynamic instability
  • initial intubation considered as difficult
  • swallowing disorders suspected
  • inefficient cough
  • bronchial hypersecretion at the weaning time
  • non cooperant patient
  • contra-indications for nasal or facial mask (facial skin lesions,...)
  • recent history of upper gastro-intestinal surgery
  • recent history of myocardial infarction

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Main end-point defined as the weaning success/failure rate

Secondary Outcome Measures

Outcome Measure
Secondary end-points :
Intubation duration
Total duration of mechanical ventilation (endotracheal and non invasive)
Weaning process duration
Daily duration of ventilatory support
ICU lentgh of stay
Hospital lentgh of stay
Complications of mechanical ventilation (endotracheal and non invasive)
Mortality at day 28

Collaborators and Investigators

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

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: christophe Girault, M.D., Rouen University Charles Nicolle Hospital (France)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2002

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001/012/HP

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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