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CompletedNCT02426242Updated Sep 13, 2016

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

An observational study in Severe Brain Injury, sponsored by Nantes University Hospital. Completed at 3 sites in France. Open to participants aged 15 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-09-13.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
15 Years to 85 Years
Sex
All
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Study 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

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Conditions studied

  • Severe Brain Injury

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Keywords

  • brain-injury
  • extubation
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 450 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized in ICU for severe brain injury

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

Exclusion Criteria:

  • Pregnant women
  • Patient consent withdrawal
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (actual)
Patient registry
No

Groups and cohorts

  • ICU PATIENTS

    Patients with brain-injury

    Other: Collection of medical data from ICU patients

Interventions

  • OtherCollection 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.

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What researchers measure

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

    Time frame: In the 48 hours following extubation

Secondary outcomes

  1. Impact of extubation failure

    Impact of extubation failure on * Duration of mechanical ventilation * Length of ICU stay * Mortality Describing reasons

    Time frame: Median 14 days after Intensive Care Unit (ICU) admission

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Study locations

3 sites
  • Angers University Hospital
    Angers, 49000, France
  • Nantes University Hospital
    Nantes, 44093, France
  • Rennes University Hospital
    Rennes, 35000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02426242
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Apr 24, 2015
Start date
Apr 2013
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Sep 13, 2016

Study contacts

Raphaël Cinotti, MD
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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