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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201303209014N17

Enrollment

Registered

2013-11-29

Start date

2013-11-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head trauma. Injury of cranial nerves

Interventions

Intervention 1: Using 80% oxygen once for 6 hours using ventilator. Intervention 2: Using 50% oxygen once for 6 hours using ventilator.

Treatment - Other

Using 80% oxygen once for 6 hours using ventilator

Using 50% oxygen once for 6 hours using ventilator

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Neurological 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

Measure	Time frame
Duration of hospitalization in intensive care unit (ICU) and neurosurgery ward. Timepoint: At discharge. Method of measurement: Medical record.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Abbas Taher

Besat Hospital

t_anesthesia@yahoo.com00

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026