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CTRI Number  CTRI/2025/06/088171 [Registered on: 03/06/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Diagnostic performance of Transcranial Colour Coded Duplex sonography (TCCD) in predicting CT scan injuries in traumatic head injury patients 
Scientific Title of Study   Diagnostic performance of Transcranial colour coded Duplex sonography (TCCD) in Predicting CT scan injuries in moderate and severe Traumatic head injury patients: A prospective observational 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  Selva kumar 
Designation  Junior resident  
Affiliation  Postgraduate institute of medical education and research  
Address  Department of Anesthesia and intensive care, level 4, Nehru hospital, postgraduate institute of medical education and research, Chandigarh , sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7397437172  
Fax    
Email  cselvakumar164@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kajal Jain  
Designation  Professor  
Affiliation  Postgraduate institute of medical education and research  
Address  Department of Anesthesia and intensive care, level 4, Nehru hospital, postgraduate institute of medical education and research, Chandigarh , sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009539  
Fax    
Email  kajalteji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kajal Jain  
Designation  Professor  
Affiliation  Postgraduate institute of medical education and research  
Address  Department of Anesthesia and intensive care, level 4, Nehru hospital, postgraduate institute of medical education and research, Chandigarh , sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009539  
Fax    
Email  kajalteji@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Postgraduate institute of medical education and research  
Address  Department of Anesthesia and intensive care, level 4, Nehru hospital, postgraduate institute of medical education and research, Chandigarh , sector 12, Chandigarh  
Type of Sponsor  Research institution and hospital 
 
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 selva kumar  PGIMER chandigarh  Advanced trauma centre triage- red area, department of anesthesiology and intensive care, Nehru hospital, PGIMER chandigarh
Chandigarh
CHANDIGARH 
7397437172

cselvakumar164@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V899||Person injured in unspecified vehicle accident,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  GCS less than 12 with history of road traffic accidents  
 
ExclusionCriteria 
Details  Failure to obtain consent
GCS 3
external injuries limiting the acoustic transtemporal window on both sides
external ocular injuries limiting bilateral ONSD measurements
patients with organ failure or severe infections prior to admission
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
correlating TCCD pulsatility index with Rotterdam scoring on CT imaging of head  on arrival to ATC triage after primary survey  
 
Secondary Outcome  
Outcome  TimePoints 
correlation of pulsatility index with Marshall scoring system   on arrival to ATC triage after primary survey 
correlation of pulsatility index with sonographic optic nerve sheath diameter   on arrival to ATC triage after primary survey  
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   15/06/2025 
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="10"
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  

AIM- 

To determine  diagnostic performance of  Point of care transcranial colour doppler sonography   for ruling -in intracranial hypertension and correlating with CT imaging  in early phase of critical head injuries during primary survey 

METHODS 

Consent for participation in the observational trial will be taken from the blood relatives of the patient. Screening for possible enrolment will begin on arrival to triage. Details of the referral and treatment given before arrival to the hospital will be recorded and entered into a performa. The primary and secondary survey will be conducted by the on-duty doctor based on Advanced Trauma Life Support (ATLS) protocol. Those patients who show a lower GCS<12 post resuscitation will be subsequently enrolled. Recording of baseline vitals (heart rate, saturation, Blood pressure) will be done utilizing vital sign bedside monitor. A Baseline arterial blood gas sample will be withdrawn from radial artery and sent for analysis.

Transcranial Colour Doppler (TCCD) will be performed on both sides in trans temporal window by using 1-5Mhz phased array ultrasound transducer Transducer will be positioned over the trans temporal window with pointer towards the patient’s front immediately in front of tragus and above the zygomatic arch over the temporal area orienting upwards anteriorly Once the contralateral and ipsilateral temporal bones are identified, cerebral puduncles and basal cistern will be visualised with its classic butterfly wing structure in the mesencephalic plane. The middle cerebral artery (MCA) will be accessed through the transtemporal window at a depth of 50-60 mm,Time of TCCD study and the blood pressure during the time of TCCD will be noted. In case of asymmetry of values on both sides, the side with higher value will be considered. A normal PI will be defined as value less than 1.2. ONSD will be measured by positioning the probe on the temporal area of the eyelid, oriented in such a way that it provides a view of the optic disc and the point where the optic nerve enters the eye. ONSD will be quantified at a location situated 3mm behind the retina. This measurement will be taken with the aid of an electronic calliper, ensuring that the measurement axis is perpendicular to the optic nerve. To enhance accuracy and minimize errors, the mean of three measurements will be derived for each eye from each patient. ONSD 5mm or above is considered abnormaL. Patients will be transferred for radiologic investigation once deemed to be stable by the treating physician. Rotterdam CT scoring and Marshall scoring will be done by the neurosurgeon who will be blinded for the TCCD findings. 

DATA

Patient demographics, referral details 

Vitals- non invasive blood pressure, heart rate, saturation on arrival till 30 mins 

Arterial blood gas

TCCD pulsatility index, ONSD , Rotterdam ct scoring, marshall ct scoring 


 
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