Brain-injured Patients Extubation Readiness Study

Summary

The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.

Conditions

• Mechanical Ventilator Weaning
• Acute Brain Injury
• Altered Level of Consciousness
• Mechanical Ventilation
• Airway Control

Interventions

PROCEDURE

Extubation readiness clinical score

After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the intervention group, after a successful spontaneous breathing trial in unconscious patients, the score will be evaluated. If the score is \> 9, extubation has to be completed.

PROCEDURE

Usual Care

After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the control group, after a successful spontaneous breathing trial in unconscious patients, the extubation will be achieved according to usual care.

Sponsors & Collaborators

• ANARLF Network

  collaborator UNKNOWN

• Direction Générale de l'Offre de Soin (DGOS)

  collaborator UNKNOWN

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Russell Chabanne · University Hospital, Clermont-Ferrand

• Olivier Vincent · University Hospital, Grenoble

• Florent Gobert · Hospices Civils de Lyon

• Jérôme Morel · CHU SAINT-ETIENNE

• Matthieu Jeannot · CH VALENCE

• Pierre-André Rodié-Talbère · Nantes University Hospital

• Thomas Geeraerts · University Hospital, Toulouse

• Pierre-François Perrigault · University Hospital, Montpellier

• Claire Roger · CHU Nîmes

• Carole Ichai · CHU NICE

• Nicolas Engrand · Fondation Ophtalmologique Adolphe de Rothschild

• Camille Bouisse · CH de Bourg-en-Bresse

• Natalie De Sa · CHU Lille

• Sigismond Lasocki · University Hospital, Angers

• Claire Dahyot-Fizelier · CHU Poitiers

• Yoann Launey · CHU Rennes

• Laurent Petit · CHU Bordeaux - Réanimation Chirurgicale et traumatologique

• Hugues De Courson · CHU Bordeaux - Réanimation Neurologique

• Clément Gakuba · CHU Caen Normandie

• Sophie Kauffmann · CHU de La Réunion

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-09

Primary Completion

2027-02-13

Completion

2027-10-13

Countries

• France

Study Locations