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Investigating the effect of hydrocortisone on reducing the amount of airway edema and the success of endotracheal tube removal in head trauma patients admitted to the intensive care unit

Investigating the effect of hydrocortisone on reducing the amount of airway edema and the success of endotracheal tube removal in head trauma patients admitted to the intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240929063203N6
Enrollment
64
Registered
2026-04-02
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Condition 1: Head trauma (Traumatic brain injury). Condition 2: Airway edema (Laryngeal edema). Unspecified intracranial injury Edema of larynx

Interventions

Intervention 1: Intervention group: Head trauma patients scheduled for extubation will receive 100 mg of intravenous hydrocortisone (stat) before endotracheal tube removal, and this dose will be repea

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: Consent of the legal representatives of the patients Patients aged 16 to 60 years Hospitalized for more than 24 hours in the ICU, intubated, and undergoing mechanical ventilation Stable hemodynamic status with no contraindications for corticosteroid therapy

Exclusion criteria

Exclusion criteria: Lack of consent from legal representatives to continue the study Brain death patients Presence of underlying pulmonary diseases Length of stay less than 24 hours in the intensive care unit Previous use of steroids Patients intubated for more than 14 days who are candidates for tracheostomy History of extubation during the same hospital admission

Design outcomes

Primary

MeasureTime frame
Success rate of endotracheal tube removal (defined as the ability to maintain spontaneous breathing without the need for re-intubation). Timepoint: Within 48 hours after extubation. Method of measurement: Clinical observation, evaluation of the patient’s respiratory status by the physician, and recording the absence of the need for re-intubation in the patient’s medical record.;Incidence of re-intubation (extubation failure). Timepoint: Within 48 hours after initial extubation. Method of measurement: Clinical recording of the need for re-intubation in the patient’s medical file located in the intensive care unit.

Secondary

MeasureTime frame
Duration of mechanical ventilation. Timepoint: From the initiation of intubation and connection to the ventilator until successful extubation. Method of measurement: Exact calculation of days and hours based on documentation and dates recorded in the patient’s clinical file.????? ?????? ???:.;Length of stay in the intensive care unit. Timepoint: From the time of the patient’s admission to the intensive care unit until discharge from this unit. Method of measurement: Calculation of hospitalization days based on the admission and discharge dates recorded in the hospital system and the patient’s file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Vatankhah

Bandare-abbas University of Medical Sciences

hormozgan91@yahoo.com+98 76 3334 5009

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026