| 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
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 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
|
|
|
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, postâ€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 highâ€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. |