NCT01201291

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury | Patient

Interventions

Type	Name	Description
OTHER	Normobaric oxygen	Fraction of inspired oxygen

Timeline

• Start date: 2010-11-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2010-09-14
• Last updated: 2018-08-14

Locations

4 sites across 1 country: Finland