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OpenTrials
Completed

NCT Number: NCT02426242

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

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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Key information

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Extubation failure

    Time frame: 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 outcomes

  1. Impact of extubation failure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Observational Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain-injured Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2015
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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