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Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury (BRAINOXY)

This study has been terminated.
(Due to slow recruitment the study was terminated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201291
First Posted: September 14, 2010
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tampere University Hospital
Turku University Hospital
Helsinki University Central Hospital
Information provided by (Responsible Party):
Stepani Bendel, Kuopio University Hospital
  Purpose
Aim of the study is to investigate the impact of two different fractions of inspired oxygen (FiO2) on outcome in patients with severe traumatic brain injury (TBI).

Condition Intervention
Traumatic Brain Injury | Patient Other: Normobaric oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Stepani Bendel, Kuopio University Hospital:

Primary Outcome Measures:
  • Glasgow outcome scale(GOS) and/or Extended glasgow outcome scale (GOSE) [ Time Frame: 6 months ]

    The study is powered to have 80% power at 5% significance level to detect a treatment effect that decreases the proportion of poor outcome from 55% to 45%.

    Each patient is given an individualized tailored prognosis based on patient's baseline prognosis in a large reference population. Outcome is measured by using functional outcome score, Glasgow outcome score (GOS) and/or GOS extended (GOSE).



Secondary Outcome Measures:
  • 6 month outcome [ Time Frame: 6 months ]

    Combined proportion of unfavourable neurological outcomes at 6 months:

    severe disability (GOSE 2-4) or death (GOSE 1):

    Occurence of lung injury during mechanical ventilation: ALI-criteria or ARDS criteria used (paO2/FiO2 ratio less than 300 or 200 respectively):

    Mortality at 6 months:

    Proportion of surviving patients with unfavourable neurological outcome at 6 months (GOSE 2-4).

    Quality of life assessment (EQ-5D) at 6 months:

    Prolonged mechanical ventilation Re-intubation rates



Enrollment: 67
Study Start Date: November 2010
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fraction of inspired oxygen of 0.4
Fraction of inspired normobaric oxygen of 0.4 (low oxygen group)
Other: Normobaric oxygen
Fraction of inspired oxygen
Active Comparator: Fraction of inspired oxygen of 0.7
Fraction of inspired normobaric oxygen of 0.7 (high oxygen group)
Other: Normobaric oxygen
Fraction of inspired oxygen

Detailed Description:

The high oxygen group is treated during mechanical ventilation with either a fraction of inspired oxygen of 0.7 (high oxygen group) or a fraction of inspired oxygen 0.4 (control group). The intervention continues until withdrawal of mechanical ventilation, ICU discharge or until 14 days from ICU randomisation.

Primary outcome is worse than expected outcome in the corresponding treatment arms based on outcome meas-ured by the probability of bad outcome using the CRASH® risk calculator (prognostic model for predicting outcome after traumatic brain injury).

Secondary outcome is occurence of lung injury during mechanical ventilation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with isolated non-penetrating traumatic brain injury
  • Multiple trauma patient with brain injury and traumas outside abdomen, thorax or pelvis not affecting oxygenation
  • Glasgow coma scale eight or less (inclusive)
  • Expected need for intubation and for mechanical ventilation more than 24 hours.
  • Are recruited <18 hours after admittance to ICU and
  • Time from TBI is less than 36 hours
  • Informed consent from patients representative

Exclusion Criteria:

  • Age <18 or >65 years,
  • Anticipated brain death in 12 hours (donor treatment) or otherwise moribund patient expected to die in 24 hours
  • Expected need for mechanical ventilation less than 24 hours
  • Insufficient oxygenation assessed by a clinician or multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation.
  • No consent
  • Insufficient oxygenation with the treatment modality of the lower oxygenation group (Pa02 less than 13 kPa or SpO2 95% with Fi02 40%, PEEP 10 or less) or oxygenation failure probable during ICU care (severe aspiration, multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation)
  • Penetrating TBI
  • No consent
  • Suspected pregnancy (perform urinary or serological pregnancy test if suspected)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201291


Locations
Finland
Helsinki University Central Hospital, Töölö Hospital
Helsinki, Töölö, Finland, 00029
Kuopio University Hospital
Kuopio, Finland, 70211
Tampere University Hospital
Tampere, Finland, 33521
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Kuopio University Hospital
Tampere University Hospital
Turku University Hospital
Helsinki University Central Hospital
Investigators
Principal Investigator: Esko Ruokonen, Professor Kuopio University Hospital
Study Director: Stepani J Bendel, MD,PhD Kuopio University Hospital
Principal Investigator: Maarit Lång, MD Kuopio University Hospital
  More Information

Responsible Party: Stepani Bendel, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01201291     History of Changes
Other Study ID Numbers: KUH5070218
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Stepani Bendel, Kuopio University Hospital:
TBI
Normobaric hyperoxia
Outcome
GOS
GOSE

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System