Traumatic Brain Injury | Patient Clinical Trial
— BRAINOXYOfficial title:
Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury
| Verified date | August 2018 |
| Source | Kuopio University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 67 |
| Est. completion date | August 1, 2018 |
| Est. primary completion date | August 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Helsinki University Central Hospital, Töölö Hospital | Helsinki | Töölö |
| Finland | Kuopio University Hospital | Kuopio | |
| Finland | Tampere University Hospital | Tampere | |
| Finland | Turku University Hospital | Turku |
| Lead Sponsor | Collaborator |
|---|---|
| Kuopio University Hospital | Helsinki University Central Hospital, Tampere University Hospital, Turku University Hospital |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |