Non Invasive Ventilation and Weaning : VENISE Trial

NCT00213499 | Completed DMC

• 1 other identifier: 2001/012/HP
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weaning; Chronic Respiratory Failure

Keywords

Mechanical ventilation; Weaning; Noninvasive ventilation; Acute on chronic respiratory failure

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

• Secondary end-points :

• Intubation duration

• Total duration of mechanical ventilation (endotracheal and non invasive)

• Weaning process duration

• Daily duration of ventilatory support

Interventions

non invasive ventilation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Charles Nicolle Hospital

Rouen, 76031, France

Location

Related Publications (2)

• Girault C, Chajara A, Dachraoui F, Chambaretaud V, Hellot MF, Benichou J, Bonmarchand G; Groupe d'Etude VENISE. [VENISE: Non-invasive ventilation during mechanical ventilation weaning in chronic respiratory failure patients. A prospective randomised controlled and multicenter trial]. Rev Mal Respir. 2003 Dec;20(6 Pt 1):940-5. French.

  PMID: 14743096 BACKGROUND

• Girault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L'Her E, Hilbert G, Capellier G, Rabbat A, Besbes M, Guerin C, Guiot P, Benichou J, Bonmarchand G; VENISE Trial Group. Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir Crit Care Med. 2011 Sep 15;184(6):672-9. doi: 10.1164/rccm.201101-0035OC.

  PMID: 21680944 RESULT

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• christophe Girault, M.D.

  Rouen University Charles Nicolle Hospital (France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2002
• Primary Completion: April 1, 2006
• Study Completion: September 1, 2008
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)