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CTRI Number  CTRI/2024/03/063902 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to know blood flow in the neck vessels 
Scientific Title of Study   Assessment of Carotid corrected flow time, volume flow and blood flow velocities in Healthy Subjects– An 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  Dr Swetha Nelluri 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS MANGALAGIRI 
Address  Department of Anesthesiology, AIIMS MANGALAGIRI

Guntur
ANDHRA PRADESH
522503
India 
Phone  9133566651  
Fax    
Email  swetha08061999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sripriya R 
Designation  Additional professor 
Affiliation  AIIMS MANGALAGIRI 
Address  Department of Anesthesiology, AIIMS MANGALAGIRI

Guntur
ANDHRA PRADESH
522503
India 
Phone  9365815939  
Fax    
Email  docsripriya@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sripriya R 
Designation  Additional professor 
Affiliation  AIIMS MANGALAGIRI 
Address  Department of Anesthesiology, AIIMS MANGALAGIRI

Guntur
ANDHRA PRADESH
522503
India 
Phone  9365815939  
Fax    
Email  docsripriya@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
AIIMS MANGALAGIRI 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Sripriya R  AIIMS MANGALAGIRI  Room no 425,Department of Anesthesiology
Guntur
ANDHRA PRADESH 
936815939

docsripriya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS MANGALAGIRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  NA 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Healthy volunteers, ASA 1 and 2, BMI of 18 to 30 
 
ExclusionCriteria 
Details  Any person unwilling to participate, having an injury, infection, or a previous surgical scar in the neck, thyroid swelling, neck swelling, post‐burn contractures, and other external anatomical malformations in the neck, and pregnant patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the carotid volume flow, peak systolic velocity, δPV, time-averaged peak velocity, end diastolic velocity and cFT.

 
single point baseline observation

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the intra-observer variability in measurements
2. To assess the interobserver variability in measurements
 
single point baseline observation 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   02/04/2024 
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="1"
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  

They will undergo a thorough history taking focussed primarily on past medical history and drug history and a brief physical examination. The hemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure will be checked and recorded. If any positive findings are detected during clinical examination such as anaemia, pedal oedema, dehydration or raised blood pressure, the volunteers will be excluded from the study.

All ultrasound measurements will be performed with the volunteers in a supine position with their head turned approximately 30° to the left side (without using a head pillow) and the ipsilateral arm adducted. All ultrasound scans will be conducted from the head end using the 35 mm high‐frequency broadband linear array transducer (HFL 13–6 MHz) of the portable Edge II (FUJIFILM Sonosite, Inc, Bothel, USA) ultrasound system. The “artery preset” will be selected and depth adjusted to get the artery at the centre of the screen. A scout scan of the right carotid artery from the upper neck to the clavicle will be done to ensure that the carotid artery does not have any obvious anatomical variations or abnormalities such as irregularities of the intima. The volunteers will be excluded if there are any anatomical variations or abnormalities.

A short axis view of the carotid artery at the level of the lower border of thyroid cartilage will be obtained and frozen. The maximum diameter of the carotid artery at this point will be recorded. All the other measurements will be taken using a longitudinal scan of the right carotid artery, with the transducer marker oriented cephalic and the mid-point of the transducer at the level of the lower border of the thyroid cartilage. Minor adjustments to the transducer will be made to obtain the same diameter of the carotid artery as was previously recorded. This will ensure that the ultrasound beam passes across the midline of the carotid artery. The anterior and posterior walls of the carotid artery on the image should be parallel and the intima visualized crisp and clear. The power doppler key will then be activated and the angle of insonation set at 60°. Once a good quality Doppler spectral trace is obtained, the image will be frozen and measurements obtained.

The maximum peak systolic velocity, the minimum peak systolic velocity and the end-diastolic velocity on the frozen waveform will be measured. The δPV will be calculated. The volume flow and time average peak (TAP) velocity will be determined using the automatic trace option after providing input for the diameter . The cFT will be determined by measuring the cycle time and systole time on the frozen image as previously described by Blehar et al. cFT will be determined using the formula systole time/√systole time.

All parameters will be measured by three observers (the PG student who will be the principal investigator, the guide and co-guide) who will be trained in carotid artery anatomy, the use of power spectral Doppler imaging and the scanning protocol. A minimum of 10 carotid scans and measurements will be done by each observer to become proficient in doing the scan and taking measurements.

Each observer will take three measurements on each subject included in the study.

 
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