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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prachi2411chaudhary@gmail.com].

  6. 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.

  7. 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.
 
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