CompletedNot Applicable

Non Invasive Ventilation and Weaning : VENISE Trial

France205 participantsStarted 2002-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00213499

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-04

View on ClinicalTrials.gov More Weaning trials