Status:
TERMINATED
Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury
Lead Sponsor:
Kuopio University Hospital
Collaborating Sponsors:
Tampere University Hospital
Turku University Hospital
Conditions:
Traumatic Brain Injury | Patient
Eligibility:
All Genders
18-65 years
Phase:
NA
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 interventi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01201291
Start Date
November 1 2010
End Date
August 1 2018
Last Update
August 14 2018
Active Locations (4)
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1
Helsinki University Central Hospital, Töölö Hospital
Helsinki, Töölö, Finland, 00029
2
Kuopio University Hospital
Kuopio, Finland, 70211
3
Tampere University Hospital
Tampere, Finland, 33521
4
Turku University Hospital
Turku, Finland, 20521