Non Invasive Ventilation and Weaning : VENISE Trial

Sponsor

University Hospital, Rouen (Other)

Overall Status

Completed

CT.gov ID

NCT00213499

Collaborator

(none)

205

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weaning Chronic Respiratory Failure	Procedure: non invasive ventilation	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)