An interventional study of Tracheostomy in Head Injury and Traumatic Brain Injury, sponsored by University Of Anbar. Completed at 1 site in Iraq. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University Of Anbar · Not applicable, Interventional, and Treatment
Tracheostomy is a surgical procedure that involves creating an opening in the trachea and bringing it to the skin surface to form a stoma. It may be performed as an emergency or elective operation. The main indications include relief of upper airway obstruction, protection of the lower respiratory tract, and facilitation of assisted ventilation in critically ill patients. Further studies are needed to identify the patient populations that may benefit from early tracheostomy. Therefore, this study was conducted to evaluate early tracheostomy (≤7 days) compared with late tracheostomy (>7 days) in relation to the occurrence of ventilator-associated pneumonia, duration of mechanical ventilation, length of hospital stay, and 30-day mortality in critically ill patients with traumatic head injury.
This study was a prospective, randomized, parallel-group, open-label controlled trial conducted among critically ill adult patients with traumatic brain injury requiring invasive mechanical ventilation.
Eligible participants were randomly assigned in a 1:1 ratio to either an early tracheostomy group or a late tracheostomy group. In the early tracheostomy group, tracheostomy was performed within 7 days of endotracheal intubation. In the late tracheostomy group, tracheostomy was performed more than 7 days after endotracheal intubation.
Due to the nature of the intervention, blinding of participants, treating physicians, and other care providers was not feasible. Both groups otherwise received standard intensive care and traumatic brain injury management according to the clinical protocols of the treating institution.
The primary outcome was the occurrence of ventilator-associated pneumonia during ICU admission. Secondary outcomes were 30-day all-cause mortality, duration of mechanical ventilation, ICU length of stay, and hospital length of stay.
Clinical and demographic information was collected using standardized data collection forms. Recorded variables included participant characteristics, severity of traumatic brain injury, Glasgow Coma Scale score, relevant radiological and clinical findings, timing of tracheostomy, occurrence of ventilator-associated pneumonia, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and mortality status.
A total of 100 participants were included in the final study population. Outcomes were compared between the early and late tracheostomy groups using appropriate statistical methods for continuous and categorical variables. Statistical significance was defined as a P value of less than 0.05.
The study was conducted following approval from the responsible ethical review authority, and informed consent was obtained from the participant or legally authorized representative as applicable.
264 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 141 interventional studies indexed under Craniocerebral Trauma.
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Exclusion Criteria:
Participants with traumatic brain injury assigned to undergo tracheostomy within 7 days of endotracheal intubation.
Procedure: Tracheostomy
Participants with traumatic brain injury assigned to undergo tracheostomy more than 7 days after endotracheal intubation.
Procedure: Tracheostomy
Tracheostomy performed in critically ill patients with traumatic brain injury according to randomized assignment to either early tracheostomy within 7 days of endotracheal intubation or late tracheostomy after 7 days.
Ventilator-Associated Pneumonia
Ventilator-associated pneumonia was assessed from 48 hours after endotracheal intubation until ICU discharge, death, or 30 days after intubation, whichever occurred first.
Time frame: Up to 30 days after ICU admission.
30-Day All-Cause Mortality
Proportion of participants who died from any cause within 30 days after tracheostomy.
Time frame: 30 days after tracheostomy.
ICU Length of Stay
Number of days from ICU admission until ICU discharge or death.
Time frame: Up to 30 days after ICU admission.
Duration of Mechanical Ventilation
number of days from initiation of invasive mechanical ventilation until successful liberation from mechanical ventilation or death.
Time frame: Up to 30 days after endotracheal intubation.
Hospital Length of Stay
Number of days from hospital admission until hospital discharge or death.
Time frame: Up to 30 days after hospital admission.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University Of Anbar