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: a double blinded randomized clinical trial

Objective: To assess the effect of hyperoxia with FIO2 80% in comparison with FIO2 50% on Glascow Outcome Scale (GOS) and Barthel Index and Modified Rankin Scale in patients with severe traumatic brain injury Design: A double blinded randomized controlled trial. Setting: The eligible patients of 15 to 65 years of age who will be admitted to intensive care unit (ICU) of Besat hospital during 2013 due to head trauma. 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 disease, cardiovascular diseases, or cancer; (c) presence of hypoxia or hypotension before intervention; (d) being undergone cardiopulmonary resuscitation; (e) needing entropic or antihypertensive medications. Intervention: using 80% oxygen once for 6 hours using ventilator Control: using 50% oxygen once for 6 hours using ventilator Primary outcome 1: measuring Glascow Outcome Scale (GOS) at discharge and 6 months later Primary outcome 2: measuring Barthel Index at discharge and 6 months later Primary outcome 3: measuring Modified Ranking Scale at discharge and 6 months later Secondary outcome: measuring the duration of hospitalization in intensive care unit (ICU) and neurosurgery ward

Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences