Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213499
Status:
COMPLETED
Last Update Posted:
2012-02-16
First Post:
2005-09-13
Brief Title:
Non Invasive Ventilation and Weaning VENISE Trial
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
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 VENISETrial
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VENISE
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 successfailure 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None