VENISE: Non-invasive ventilation for the weaning of mechanical ventilation in acute-on-chronic respiratory failure patients. A prospective randomised controlled and multicenter trial

Introduction The clinical efficacy of non-invasive ventilation (NIV) has now been demonstrated in the management of acute-on-chronic respiratory failure (ACRF) in 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 useful to consider NIV for delivering effective ventilatory support to reduce the length of ETMV in ACRE patients who are still not capable of maintaining spontaneous breathing. From the interesting but discordant results of two recent randomised controlled trials, a working group from the Societe de Reanimation de Langue Francaise (SRLF) decided to perform a new prospective randomised controlled multicenter trial. The aim of the study will be to assess the usefulness of NIV as an extubation and weaning technique in ventilated ACRF patients. Methods The methodology used will compare three parallel weaning strategies in ACRE 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 rate, 208 patients from 17 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. Expected results Results of the VENISE trial should permit to improve the management of the difficult to wean ACRF patients and thus contribute to more precisely, define the place of NIV in the weaning and prevention of re-intubation strategies in these patients.