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

NCT ID: NCT01201291

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2018-08-01

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.

Conditions

Traumatic Brain Injury | Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fraction of inspired oxygen of 0.4

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

Group Type: ACTIVE_COMPARATOR

Normobaric oxygen

Intervention Type: OTHER

Fraction of inspired oxygen

Fraction of inspired oxygen of 0.7

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

Group Type: ACTIVE_COMPARATOR

Normobaric oxygen

Intervention Type: OTHER

Fraction of inspired oxygen

Interventions

Normobaric oxygen

Fraction of inspired oxygen

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stepani Bendel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esko Ruokonen, Professor

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Stepani J Bendel, MD,PhD

Role: STUDY_DIRECTOR

Kuopio University Hospital

Maarit Lång, MD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

Helsinki University Central Hospital, Töölö Hospital

Helsinki, Töölö, Finland

Kuopio University Hospital

Kuopio, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

KUH5070218

Identifier Type: -

Identifier Source: org_study_id