NCT02235376

Brief Summary

Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

July 28, 2014

Last Update Submit

October 13, 2015

Conditions

Brain Injury

Keywords

Critical CareBrain injured patientsMechanical VentilationWeaningExtubationPrognostic scoreClinical examination

Outcome Measures

Primary Outcomes (1)

  • Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation

    \- 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 Outcomes (9)

  • Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU

    at ady 1

  • Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU

    at day 1

  • Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU

    at day 1

  • Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation

    at day 1

  • cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay

    at day 1

  • +4 more secondary outcomes

Study Arms (1)

critical care

Other: weaning trial of mechanical ventilation

Interventions

weaning trial of mechanical ventilationOTHER
critical care

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

brain injured patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Russell CHABANNE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

September 10, 2014

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

FR(1)