Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score. (GODWEAN)

October 13, 2015 updated by: University Hospital, Clermont-Ferrand
Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective clinical study in ICU with brain injured ventilated patients eligible to extubation.

Identification of clinical and biological criteria associated with failure of extubation.

Elaboration of a prognostic score of extubation failure of brain injured patients, based on criteria previously identified with multivariate analysis.

Failure of extubation is defined by the need of re-intubation or the need for non-invasive ventilation within 48 hours or more after extubation.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

brain injured patients

Description

Inclusion Criteria:

  • Adult brain injured patients ventilated eligible to discontinuation of mechanical ventilation
  • Stable respiratory and hemodynamic conditions
  • Ventilated patients for more than 48 hours
  • Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%, positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥ 7mL/kg
  • Therapeutic extubation

Exclusion Criteria:

  • • Status epilepticus

    • Cerebrospinal infection
    • Patients under 15 years old
    • Mechanical ventilation of < 48 h
    • Spinal cord injury
    • Withdrawal of life support

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
critical care
Other: weaning trial of mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation
Time Frame: at day 2
- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay
at day 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU
Time Frame: at ady 1
at ady 1
Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU
Time Frame: at day 1
at day 1
Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU
Time Frame: at day 1
at day 1
Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation
Time Frame: at day 1
at day 1
cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay
Time Frame: at day 1
at day 1
- Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation
Time Frame: at day 1
at day 1
- Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)
Time Frame: at day 2
at day 2
Delay of extubation from intubation day (number of days)
Time Frame: at day 1
at day 1
Glasgow Outcome Score (GOS)
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Russell CHABANNE, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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