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:
Collaborators:
Tampere University Hospital
Turku University Hospital
Helsinki University Central Hospital
Information provided by (Responsible Party):
Stepani Bendel, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01201291
First received: September 13, 2010
Last updated: December 20, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Kuopio University Hospital:

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

    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 ] [ Designated as safety issue: Yes ]

    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: December 2015
Estimated Primary Completion Date: December 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stepani Bendel, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01201291     History of Changes
Other Study ID Numbers: KUH5070218
Study First Received: September 13, 2010
Last Updated: December 20, 2013
Health Authority: Research Ethics Committee, Hospital District of Northern Savo: Finland

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

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

ClinicalTrials.gov processed this record on October 22, 2014