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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02426242
• Collaborator: (none)
• Enrollment: 450
• Locations: 3
• Duration (Months): 15
• Patients Per Site: 150
• Patients Per Site Per Month: 10

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Severe Brain Injury	Other: Collection of medical data from ICU patients

Study Design

• Study Type: Observational
• Actual Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
ICU PATIENTS Patients with brain-injury	Other: Collection of medical data from ICU patients; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Angers University Hospital	Angers		France	49000
2	Nantes University Hospital	Nantes		France	44093
3	Rennes University Hospital	Rennes		France	35000

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Raphaël Cinotti, MD, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT02426242
• Other Study ID Numbers: RC13_0354
• First Posted: Apr 24, 2015
• Last Update Posted: Sep 13, 2016
• Last Verified: Apr 1, 2015

• Keywords provided by Nantes University Hospital: brain-injury; extubation
• Additional relevant MeSH terms: Brain Injuries

Study Results

No Results Posted as of Sep 13, 2016