| CTRI Number |
CTRI/2026/02/104405 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
An Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
The component of this ultrasound measurement track how much a neck vein expands during exposure to pressure changes from ventilator ,helping doctors actually predict if an elderly patient needs more IV fluids to keep their blood pressure stable during surgery. |
|
Scientific Title of Study
|
Internal jugular vein distensibility index as a predictor of fluid responsivenss in elderly patient undergoing elective surgery. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1334-6724 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sidharth Satheesh |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College And Research Centre |
| Address |
Room No.211 Department Of Anaesthesia Teerthanker Mahaveer Medical College And Research Centre N.H-24,Delhi Road,Moradabad -244001,Uttar Pradesh ,India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8594056628 |
| Fax |
|
| Email |
sidharthsatheesh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MD Shabhaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College And Research Centre |
| Address |
Room No.211 Department Of Anaesthesia Teerthanker Mahaveer Medical College And Research Centre N.H-24,Delhi Road,Moradabad -244001,Uttar Pradesh ,India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshabhaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MD Shabhaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College And Research Centre |
| Address |
Room No.211 Department Of Anaesthesia Teerthanker Mahaveer Medical College And Research Centre N.H-24,Delhi Road,Moradabad -244001,Uttar Pradesh ,India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshabhaz006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre,Delhi Road,Moradabad-244001,Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre,Delhi Road,Moradabad-244001,Uttar Pradesh. |
| Type of Sponsor |
Private medical college |
|
|
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 Sidharth Satheesh |
Teerthanker Mahaveer Medical College and Research Centre |
Room no 4,Main OT Complex ,Department of Anaesthesia ,Teerthanker Mahaveer Medical College and Research Centre ,Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH |
8594056628
sidharthsatheesh1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
61.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients scheduled for elective surgery under general anaesthesia.
2)American Society of Anaesthesiology (ASA) physical status I-III
3)Patients who provide written informed consent.
4)Patients with normal sinus rhythm and hemodynamic stability before induction. |
|
| ExclusionCriteria |
| Details |
1)Patients with known cardiovascular conditions (e.g.,heart failure ,arrhythmias,valvulkar disease).
2)Presence of jugular vein thrombosis,neck anatomical abnormalities,or history of neck surgery.
3)Patients with signs of fluid overload or severe dehydration.
4)Prior Jugular vein catheterization or superiror vena cava syndrome. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Internal jugular vein distensibility index as a predictor of fluid responsiveness in elderly patients undergoing elective surgery |
30min,1 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation between changes in IJV-DI & changes in stroke volume for identifying fluid responsiveness |
30 mins,1 hr |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="6"
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
|
This study seeks to determine whether assessment of the internal jugular vein distensibility index (IJV DI)a reliable non-invasive ultrasound marker that correlates with stroke volume changes and predicts fluid responsiveness in elderly patients. We aim for the early identification of patients prone to intraoperative hypotension and allow preemptive preparation of vasopressors ensuring prompt management and hemodynamic stability. Compared to invasive methods or technically difficult Inferior Vena Cava/Superior Vena Cava assessments, IJV DI is easier to visualize and measure, even in pregnant or high-risk patients.
|