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
|
|
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
|
|
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
|
|
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
|