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

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).

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury | Patient
• Intervention / Treatment: Other: Normobaric 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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70211
    • Kuopio University Hospital
  • Tampere, Finland, 33521
    • Tampere University Hospital
  • Turku, Finland, 20521
    • Turku University Hospital
  • Töölö
    • Helsinki, Töölö, Finland, 00029
      • Helsinki University Central Hospital, Töölö Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow outcome scale(GOS) and/or Extended glasgow outcome scale (GOSE)	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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 month outcome	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	6 months

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Tampere University 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

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: TBI; Outcome; Normobaric hyperoxia; GOS; GOSE
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: KUH5070218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided