search
Back to results

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

Primary Purpose

Traumatic Brain Injury | Patient

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Normobaric oxygen
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury | Patient focused on measuring TBI, Normobaric hyperoxia, Outcome, GOS, GOSE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Helsinki University Central Hospital, Töölö Hospital
  • Kuopio University Hospital
  • Tampere University Hospital
  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fraction of inspired oxygen of 0.4

Fraction of inspired oxygen of 0.7

Arm Description

Fraction of inspired normobaric oxygen of 0.4 (low oxygen group)

Fraction of inspired normobaric oxygen of 0.7 (high oxygen group)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2010
Last Updated
August 13, 2018
Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital, Turku University Hospital, Helsinki University Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01201291
Brief Title
Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury
Acronym
BRAINOXY
Official Title
Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Due to slow recruitment the study was terminated
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital, Turku University Hospital, Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury | Patient
Keywords
TBI, Normobaric hyperoxia, Outcome, GOS, GOSE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fraction of inspired oxygen of 0.4
Arm Type
Active Comparator
Arm Description
Fraction of inspired normobaric oxygen of 0.4 (low oxygen group)
Arm Title
Fraction of inspired oxygen of 0.7
Arm Type
Active Comparator
Arm Description
Fraction of inspired normobaric oxygen of 0.7 (high oxygen group)
Intervention Type
Other
Intervention Name(s)
Normobaric oxygen
Intervention Description
Fraction of inspired oxygen
Primary Outcome Measure Information:
Title
Glasgow outcome scale(GOS) and/or Extended glasgow outcome scale (GOSE)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
6 month outcome
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esko Ruokonen, Professor
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stepani J Bendel, MD,PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maarit Lång, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital, Töölö Hospital
City
Helsinki
State/Province
Töölö
ZIP/Postal Code
00029
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs