Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00213499 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Non Invasive Ventilation and Weaning : VENISE Trial

Study acronym: VENISE
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: details revised at 1 of 2 entriesv6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: Apr 2006 Completion date: Jul 2006 to Sep 2008 · Secondary endpoints revised (9) · Primary endpoint revisedv4 Show 3 more changesShow less
    • Completion date: Jul 2006 to Sep 2008
    • Secondary endpoints revised (9)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Completed Completion date: Dec 2005 to Jul 2006 · Site details revisedv3 Show 2 more changesShow less
    • Completion date: Dec 2005 to Jul 2006
    • Site details revised
  5. Completion date: Dec 2005v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00213499
Lead Sponsor University Hospital, Rouen
Conditions Weaning, Chronic Respiratory Failure
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov