Non Invasive Ventilation and Weaning : VENISE Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213499
First received: September 13, 2005
Last updated: February 14, 2012
Last verified: February 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014