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Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Acute cerebral lesion with a Glasgow Coma Scale \<13 needing admission in ICU and mechanical ventilation with tracheal intubation for neurological cause : cerebrovascular stroke either ischemic or hemorrhagic including aneurysmal subarachnoid hemorrhage, traumatic brain injury, anoxo ischemic encephalopathy after cardiac arrest or brain tumour

• Mechanical ventilation more than 48 hours

• 18 to 75 years old

• Neurological stability with no intracranial hypertension with minimal sedation

• Glasgow Coma Scale motor response \< 6

• Spontaneous breathing trial succeeded

• First extubation attempt

Locations
Other Locations
France
CHU
RECRUITING
Angers
CHU
RECRUITING
Bordeaux
CHU
RECRUITING
Bordeaux
CH
TERMINATED
Bourg-en-bresse
CHU
RECRUITING
Caen
CHU
RECRUITING
Clermont-ferrand
CHU
COMPLETED
Grenoble
CHU
RECRUITING
La Réunion
CHU
RECRUITING
Lille
Hospices Civils de Lyon
RECRUITING
Lyon
APHM
WITHDRAWN
Marseille
CHU
RECRUITING
Montpellier
CHU
COMPLETED
Nantes
Pasteur 2 Hospital - University Hospital
TERMINATED
Nice
CHU
RECRUITING
Nîmes
Fondation Ophtalmologique Adolphe de Rothschild
RECRUITING
Paris
CHU
RECRUITING
Poitiers
CHU
RECRUITING
Rennes
CHU
COMPLETED
Saint-etienne
CHU
RECRUITING
Toulouse
CH
TERMINATED
Valence
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
+33 4 73 754963
Time Frame
Start Date: 2020-02-09
Estimated Completion Date: 2027-10-13
Participants
Target number of participants: 660
Treatments
Active_comparator: Usual care
Clinicians decide whether to extubate or not following usual care in their ICU ventilator weaning protocol
Experimental: Extubation readiness clinical score
Clinicians decide whether to extubate or not following the extubation readiness clinical score as part of their ICU ventilator weaning protocol
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Clermont-Ferrand
Collaborators: ANARLF Network, Direction Générale de l'Offre de Soin (DGOS)

This content was sourced from clinicaltrials.gov