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

NCT02426242 | Completed

• 1 other identifier: RC13_0354
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 3

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

Conditions

Severe Brain Injury

Keywords

brain-injury; extubation

Outcome Measures

Primary Outcomes (1)

• Extubation failure

  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

  In the 48 hours following extubation

Secondary Outcomes (1)

• Impact of extubation failure

  Median 14 days after Intensive Care Unit (ICU) admission

Study Arms (1)

ICU PATIENTS

Patients with brain-injury

Other: Collection of medical data from ICU patients

Interventions

Collection of medical data from ICU patients OTHER

A code will be applied to each patient included. Medical data such as demography, ISS, clinical exam at time of extubation, extubation failure, tracheotomy, will be collected during ICU stay.

ICU PATIENTS

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in ICU for severe brain injury

You may qualify if:

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

You may not qualify if:

• Pregnant women
• Patient consent withdrawal

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

Angers University Hospital

Angers, 49000, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Raphaël Cinotti, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 13, 2016

Record last verified: 2015-04

Locations

FR (3)