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CTRI Number  CTRI/2026/01/100371 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Timing of Tracheostomy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Effect of early versus late tracheostomy on ventilator duration and ICU stay in severe head injury patients” 
Scientific Title of Study   Comparison of Effect of Early Versus Late Tracheostomy on outcomes in Severe Traumatic Brain Injury: A Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alan Joseph Abraham 
Designation  Junior Resident 
Affiliation  AIIMS Patna 
Address  Department of Trauma Surgery and Critical Care, AIIMS Patna, Phulwarisharif

Patna
BIHAR
801507
India 
Phone  8800647668  
Fax    
Email  alanja1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Dr. Anil Kumar 
Designation  Professor and Head of Department 
Affiliation  AIIMS Patna 
Address  Department of Trauma Surgery and Critical Care, AIIMS Patna, Phulwarisharif

Patna
BIHAR
801507
India 
Phone  9835699103  
Fax    
Email  dranil4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Alan Joseph Abraham 
Designation  Junior Resident 
Affiliation  AIIMS Patna 
Address  Department of Trauma Surgery and Critical Care, AIIMS Patna, Phulwarisharif

Patna
BIHAR
801507
India 
Phone  8800647668  
Fax    
Email  alanja1996@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  Department of Trauma Surgery and Critical Care, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alan Joseph Abraham  AIIMS Patna  Neurotrauma ICU, Trauma centre, Department of Trauma Surgery and Critical Care, AIIMS Patna, Phulwarisharif, Patna-801507, Bihar, India
Patna
BIHAR 		 8800647668

alanja1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, AIIMS PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S06||Intracranial injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early tracheostomy  Tracheostomy on Day 3(72hrs-96hrs) of mechanical ventilation. 
Comparator Agent  Late Tracheostomy  Tracheostomy on Day 5(120hrs-144hr) of mechanical ventilation. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  Polytrauma with major chest/abdominal injuries.
Patients with cervical spine injury.
Patient with known coagulopathy.
Those who don’t give consent for this study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of mechanical ventilation between early and late tracheostomy groups.
 		 Baseline: At enrollment / at ICU admission before tracheostomy
During ICU stay: Daily assessment until ICU discharge or death
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of ventilator-associated pneumonia (VAP)  Baseline: At enrollment / at ICU admission before tracheostomy
During ICU stay: Daily assessment until ICU discharge or death
 
To assess ICU & hospital length of stay  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 discharge  At hospital discharge day 
tracheostomy-related complications  Daily assessment until discharge or death 
To assess 30-day mortality  On the day of death if within 30days of needing mechanical ventilation. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective, open-label, randomized controlled trial conducted at a tertiary care center to compare the effect of early versus late tracheostomy on clinical outcomes in patients with severe traumatic brain injury that is GCS less than or equal to 8. Eligible patients anticipated to require mechanical ventilation for more than 72 hours will be randomized into two groups- early tracheostomy performed on Day 3 and late tracheostomy performed on Day 5 of mechanical ventilation. The primary outcome is duration of mechanical ventilation. Secondary outcomes include incidence of ventilator-associated pneumonia, length of ICU and hospital stay, Glasgow Outcome Scale at discharge, tracheostomy-related complications, and 30-day mortality. The study aims to generate evidence to guide optimal timing of tracheostomy in severe head injury patients. 
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