| CTRI Number |
CTRI/2025/01/079060 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Day 1 versus day 5 tracheostomy in brain injury patients |
|
Scientific Title of Study
|
The effect of very early tracheostomy versus early tracheostomy on weaning from mechanical ventilation in patient with moderate to severe traumatic brain injury- A Prospective randomized comparative study |
| Trial Acronym |
VEET- TBI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MAHESHVARAN M |
| Designation |
Senior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care, PGIMER, Madhya Marg, Sector 12, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6363151415 |
| Fax |
- |
| Email |
maheshvaran1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHALVI MAHAJAN |
| Designation |
Assisstant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care, PGIMER, Madhya Marg, Sector 12, Chandigarh.
.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087174849 |
| Fax |
|
| Email |
drshalvimahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHALVI MAHAJAN |
| Designation |
Assisstant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesiology and Critical care, PGIMER, Madhya Marg, Sector 12, Chandigarh.
.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087174849 |
| Fax |
|
| Email |
drshalvimahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care, PGIMER, sector 12, Chandigarh, India 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Department of Anaesthesiology and Critical Care, PGIMER, sector
12, Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maheshvaran |
Postgraduation Insitute of Medical Education and Research |
Bed 1-8, Trauma intensive care
unit, level 3, Advanced trauma centre, Post graduate institute of medical education.
Chandigarh
CHANDIGARH |
8526168414
maheshvaran1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee (INTRAMURAL) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EARLY TRACHEOSTOMY |
Day 5 of ICU stay |
| Intervention |
very early tracheostomy |
Day 1 ICU stay |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with isolated moderate to severe TBI (GCS 6-12)
2.Rotterdam score 3 and above
3.ASA IE, IIE, IIIE
4.Presentation to hospital within 24 hours of injury
5.Consent for participation in the study from legal heir |
|
| ExclusionCriteria |
| Details |
1.Patients with hemoglobinopathies, deranged coagulation parameters.
2.Preoperative hemodynamically unstable patients requiring vasopressors / inotropes, polytrauma.
3.Pregnant patients
4.Patients with chronic liver disease, renal disease and decompensated heart failure
5.History of emergency tracheostomy
6. Anatomical deformity of the neck
7.Refusal to participate in the study
8. Severe respiratory distress with refractory hypoxemia and hypercapnia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration taken to wean off from mechanical ventilator in terms of number of days |
First point of ventilator free. It will be in days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of VAP (ventilator associated pneumonia)
2.Incidence of tracheostomy related complication
3.Amount of sedation required after tracheostomy till 3 days from tracheostomy
4.Complications in ICU such as deep vein thrombosis, Decubitus ulcer, sepsis, etc
5.Length of ICU stay.
6.Length of hospital stay.
7.GOSE at discharge and at1 month.
8.In hospital mortality and mortality at 1 month |
From the day of tracheostomy to 1 month from the day of discharge. |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="0"
Months="11"
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
|
Patients with TBI have to be admitted in intensive care unit (ICU) for comprehensive systemic and cerebral care. According to the CENTER-TBI study, 31% of TBI patients required tracheostomies. Traditionally, tracheostomies conducted within the first week are classified as early, whereas those performed after seven days are considered late. Early tracheostomy is thought to potentially reduce the duration of MV and the length of ICU stay. It may also decrease the risk of VAP and other complications associated with prolonged intubation. On the other hand, late tracheostomy might reduce the immediate risks associated with the procedure and allow for a better assessment of the patient’s potential for recovery. Therefore, lack of clarity underscores the need of further prospective studies to improve outcome of TBI patients requiring tracheostomy. In our study, traumatic brain injury patients will be be grouper as Group VE- Patients belong to group VE will get tracheostomy done in day 1 of admission to NTICU. Group ET- Patients belong to ET will get tracheostomy done on day 5 of admission to NTICU. Primary outcome - number of days to wean off from ventilator and also we study number of days patient takes to discharge, occurrence ventilator associated pneumonia, sepsis and any other complications in ICU. |