| CTRI Number |
CTRI/2026/03/105198 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Internal jugular vein distensibility index for fluid responsiveness |
|
Scientific Title of Study
|
Assessment of fluid responsiveness using internal jugular vein distensibility index in major abdominal surgeries during intra operative period. |
| 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 Sarika Katiyar |
| Designation |
Professor |
| Affiliation |
Bhopal Memorial Hospital and Research Centre |
| Address |
Department of Anaesthesia and Critical Care
Bhopal Memorial Hospital and Research Centre
Bhopal MADHYA PRADESH 462038 India |
| Phone |
9425019665 |
| Fax |
|
| Email |
sarikakatiyar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sarika Katiyar |
| Designation |
Professor |
| Affiliation |
Bhopal Memorial Hospital and Research Centre |
| Address |
Department of Anaesthesia and Critical Care
Bhopal Memorial Hospital and Research Centre
Bhopal MADHYA PRADESH 462038 India |
| Phone |
9425019665 |
| Fax |
|
| Email |
sarikakatiyar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prachi Chaudhary |
| Designation |
PG Resident |
| Affiliation |
Bhopal Memorial Hospital and Research Centre |
| Address |
Department of Anaesthesiology and Critical Care
Bhopal Memorial Hospital and Research Centre
Bhopal MADHYA PRADESH 462038 India |
| Phone |
7532053475 |
| Fax |
|
| Email |
prachi2411chaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesia Department
Bhopal Memorial Hospital and Research Centre
462038
Bhopal Madhya Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Anaesthesia Department Bhopal Memorial Hospital and Research Center |
| Address |
Bhopal Memorial Hospital and Research Centre
462038
Karond Bhopal
Madhya Pradesh India
Madhya Pradesh India |
| 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 Prachi Chaudhary |
Bhopal Memorial Hospital and Research Centre |
Anaesthesia Department
Operating Theatre
Karond Bypass Road
462038
Bhopal
Madhya Pradesh
India Bhopal MADHYA PRADESH |
7532053475
prachi2411chaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhopal Memorial Hospital and Research Centre Institutional Ethics Committee IEC BMHRC Research Projects Clinical Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal Renal failure Pregnant failures BMI more than 35 Neck swellings Right heart failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonographic measurements of IJV distensibility index in predicting fluid responsiveness in major abdominal surgeries |
IJV diameter will be measured before induction of general anaesthesia and after induction and after surgical incision and again it will be measured at one hour interval throughout the surgery and last measurement will be after surgical closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To relate internal jugular vein distensibility index with pulse pressure variation in assessing the preload status |
Pulse pressure variation will be measured before induction of general anaesthesia & after induction & after surgical incision & again it will be measured at one hour interval throughout the surgery & last measurement will be after surgical closure |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/03/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prachi2411chaudhary@gmail.com].
- For how long will this data be available start date provided 28-01-2026 and end date provided 28-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
General Anesthesia causes systemic vasodilation and reduced venous return which is accompanied by hypotension which leads to tissue hypoperfusion and post operative complications like renal injury, ischemic stroke, myocardial injury, prolonged hospitalization and post operative mortality. Hypotension is defined as MAP less than 65mm Hg or BP less than 20% of the baseline value. This is particularly relevant in major abdominal surgeries which are high risk and associated with fluid shifts, blood loss and anesthetic induced hemodynamic instability. Hypovolemia si the most common modifiable risk factor for hypotension after anesthetic administration. Hence intra operative fluid management and assessment of volume status plays a vital role in major abdominal surgeries hence ensuring adequate tissue perfusion and hemodynamic stability. Therefore accurate and timely assessment of fluid responsiveness becomes crucial to guide volume resuscitation. Fluid responsiveness is defined as patient’s ability to increase stroke volume or the cardiac output more than 10% ni response to fluid administration. Standard fluid challenge test will be done using 300ml of crystalloid which can significantly increase the stroke volume or the cardiac output in response to fluid administration. Fluid responsiveness can be predicted by both invasive and non invasive dynamic parameters. Arterial pulse pressure variation is an invasive dynamic parameter that relies on cycle changes in stroke volume and arterial pressure during the respiratory cycle ni mechanically ventilated patients. Non invasive parameter like ultrasonography of Internal Jugular Vein will be done to predict the volume status of the patient. IJV measurements including maximum diameter, minimum diameter and distensibility index will be measured in supine position using a linear ultrasound 5-12MHz. Observation will be done for baseline values and after induction, after incision, and then hourly and last measurement will be taken after closure of the surgical incision. PPV measurements wil also be taken at the same observation points. The changes ni IJV DI and PPV will thus be analyzed for any correlation in mechanically ventilated patients. |