| CTRI Number |
CTRI/2024/12/077962 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Transcranial doppler based management] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of management in paediatric brain injury patients using Transcranial doppler versus conventional management. |
|
Scientific Title of Study
|
Pediatric cerebral performance category score based prediction of outcome in pediatric traumatic brain injury patients comparing transcranial doppler versus conventional management in neurocritical care a randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asmita Gupta |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesiology and Critical Care, PGIMER, sector 12-Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8449186944 |
| Fax |
|
| Email |
asmitag395@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care, PGIMER, sector 12-Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087422950 |
| Fax |
|
| Email |
Dr.RajeevChauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care, PGIMER, sector 12-Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087422950 |
| Fax |
|
| Email |
Dr.RajeevChauhan@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 Asmita Gupta |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Trauma intensive care unit, Neuroanesthesia division, Department of Anesthesiology, Postgraduate Institue of Medical Education and Research, sector 12, Chandigarh, India
160012
Chandigarh
CHANDIGARH |
8449186944
asmitag395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison between transcranial doppler based management versus conventional management in paediatric traumatic brain injury patients. |
Patient will be divided into two groups:
Group A: Patients will be managed based on the Pulsatality index(PI) measured using transcranial doppler (TCD) for initial 72 hours from admission to Intensive care unit.
Group B: Patient will be managed according to conventional Intensive care unit protocols. |
| Intervention |
Transcranial doppler |
Patient will be managed by measuring Pulsatality Index (PI) using transcranial doppler, if PI is more than 1.2, 3% Hypertonic saline will be infused at 1.5ml/kg. TCD will be repeated every 12 hourly along with Full Outline of Unresponsiveness (FOUR) score evaluation for initial 72 hours from admission to Intensive care unit. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Consent given by parents or guardian
Moderate traumatic brain injury (Glassgow coma scale 9-12)
Severe traumatic brain injury (Glassgow coma scale less than 8) |
|
| ExclusionCriteria |
| Details |
Previous history of traumatic brain injury
Visual disorder that precluded neurocognitive testing
Presence of a neurological condition other than traumatic brain injury confirmed or reported by parents
Mild traumatic brain injury
Patients expired within 3 months of ICU discharge |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the short-term neurological outcome in paediatric head injury patients at discharge and at 3 months on the basis of score called Paediatric Cerebral Performance Category (PCPC) score. |
At discharge and at 3 months after discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Initial Rotterdam Computed tomography score for prediction of outcome.
2. FOUR score based assessment and prediction of outcome of all paediatric head injury patients. |
At discharge and at 3 months from discharge. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2025 |
| 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="1"
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
|
Paediatric head injury is a significant concern globally. A variety of advanced
diagnostic and monitoring devices to manage acute traumatic brain injury (TBI) effectively.
These tools are crucial for detecting both primary and secondary brain injuries and guiding
therapy for optimal management. TCD is commonly used non-invasive technique for ICP measurement in ICU and Operation
theatres. TCD allows evaluation of ICP by measuring Pulsatility index (PI) values of the middle
cerebral and other cerebral vessels, cerebral blood flow mean velocities. PI values
greater than 1.2 represent high resistance blood flow and has been most associated with
increased ICP. For an assessment of general function status in large scale paediatric studies the Paediatric
Cerebral Performance Category (PCPC) score is more reliable and suitable. Hence, we plan to conduct a randomised control trial to assess the neurological outcome in
paediatric head injury patients in TCD based management group versus conventional
management group using PCPC score. |