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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Fraction of inspired oxygen
Helsinki University Central Hospital, Töölö Hospital
Helsinki, Töölö, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
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).
Time frame: 6 months
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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.