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Effect of early versus late tracheostomy on ventilator duration and ICU stay in severe head injury patients

Comparison of Effect of Early Versus Late Tracheostomy on outcomes in Severe Traumatic Brain Injury: A Randomized Controlled Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100371
Enrollment
72
Registered
2026-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: S06- Intracranial injury

Interventions

Intervention1: Early tracheostomy: Tracheostomy on Day 3(72hrs-96hrs) of mechanical ventilation. Control Intervention1: Late Tracheostomy: Tracheostomy on Day 5(120hrs-144hr) of mechanical ventilation

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Those who will give consent for the study. Consent will be obtained from the legally authorized representative or next of kin. Isolated severe head injury. GCS less than 8. Patient requiring prolonged ventilator support more than 72 hours in view of demonstrable traumatic brain injury on CT head.

Exclusion criteria

Exclusion criteria: Polytrauma with major chest/abdominal injuries. Patients with cervical spine injury. Patient with known coagulopathy. Those who don t give consent for this study.

Design outcomes

Primary

MeasureTime frame
To compare the duration of mechanical ventilation between early and late tracheostomy groups. Timepoint: Baseline: At enrollment / at ICU admission before tracheostomy During ICU stay: Daily assessment until ICU discharge or death

Secondary

MeasureTime frame
To compare the incidence of ventilator-associated pneumonia (VAP)Timepoint: Baseline: At enrollment / at ICU admission before tracheostomy During ICU stay: Daily assessment until ICU discharge or death ;To assess ICU & hospital length of stayTimepoint: Day when patient is stepped down from ICU care & transferred to the ward At discharge: At hospital discharge;To compare Glasgow Outcome Scale (GOS) at dischargeTimepoint: At hospital discharge day;tracheostomy-related complicationsTimepoint: Daily assessment until discharge or death;To assess 30-day mortalityTimepoint: On the day of death if within 30days of needing mechanical ventilation.

Countries

India

Contacts

Public ContactDr Alan Joseph Abraham

AIIMS Patna

dranil4@gmail.com9835699103

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026