Non Invasive Ventilation and Weaning : VENISE Trial - Full Text View

Purpose

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	Intervention
Weaning Chronic Respiratory Failure	Procedure: non invasive ventilation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

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

Estimated Enrollment:	205
Study Start Date:	January 2002
Study Completion Date:	September 2008
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213499

Locations

France
Rouen University Charles Nicolle Hospital
Rouen, France, 76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

christophe Girault, M.D.

Rouen University Charles Nicolle Hospital (France)

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Guérin C, Guiot P, Bénichou 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.

Responsible Party:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213499 History of Changes
Other Study ID Numbers:	2001/012/HP
Study First Received:	September 13, 2005
Last Updated:	February 14, 2012
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Rouen:

Mechanical ventilation
Weaning
Noninvasive ventilation
Acute on chronic respiratory failure

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013