Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain Injured Patients.

Completed

• Conditions: Severe Brain Injury
• Interventions: Other: Collection of medical data from ICU patients

• Registration Number: NCT02426242
• Lead Sponsor: Nantes University Hospital

Brief Summary

Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation.

To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-04
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring ≥ 48 hours of mechanical ventilation after admission

Exclusion Criteria

• Pregnant women
• Patient consent withdrawal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU PATIENTS	Collection of medical data from ICU patients	Patients with brain-injury

Primary Outcome Measures

Name	Time	Method
Extubation failure	In the 48 hours following extubation	Extubation failure is regarded as the need of intubation in the 48 hours following extubation Establish clinial signs before extubation that can predict extubation failure Realization of a systematic clinical examination by the attending physician before performing extubation in severe brain-injured patients

Secondary Outcome Measures

Name	Time	Method
Impact of extubation failure	Median 14 days after Intensive Care Unit (ICU) admission	Impact of extubation failure on; * Duration of mechanical ventilation; * Length of ICU stay; * Mortality Describing reasons

Trial Locations

Locations (3)

Angers University Hospital; 🇫🇷 Angers, France

Nantes University Hospital; 🇫🇷 Nantes, France

Rennes University Hospital; 🇫🇷 Rennes, France