Effect of hyperoxia with FIO2 80% in comparison with FIO2 50% on Glascow Outcome Scale, Barthel Index and Modified Ranking Scale in patients with severe traumatic brain injury
Phase 3
- Conditions
- Head trauma.Injury of cranial nerves
- Registration Number
- IRCT201303209014N17
- Lead Sponsor
- Vice chancellor for Research the Technology, Hamadan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
(a) age of 4-12 years of both genders; (b) no indication of brain surgery; (c) not admitted later than 6 hours; and (d) stable hemodynamic status.
Exclusion criteria: (a) simultaneous trauma to vertebral column or other parts of the body; (b) having chronic diseases such as diabetes, chronic pulmonary diseases, cardiovascular diseases, or cancer; (c) presence of hypoxia or hypotension before intervention; (d) being undergone cardiopulmonary resuscitation; (e) needing entropic or antihypertensive medications.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurological function. Timepoint: At discharge and 6 months later. Method of measurement: Glascow Outcome Scale (GOS).;Neurological function. Timepoint: At discharge and 6 months later. Method of measurement: Barthel Index.;Neurological function. Timepoint: At discharge and 6 months later. Method of measurement: Modified Ranking Scale.
- Secondary Outcome Measures
Name Time Method Duration of hospitalization in intensive care unit (ICU) and neurosurgery ward. Timepoint: At discharge. Method of measurement: Medical record.