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CTRI Number  CTRI/2024/05/067652 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 17/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To check the usefulness of ultrasound calculated neck vein distensibility index for predicting the response to fluid therapy during surgery. 
Scientific Title of Study   Evaluation of internal jugular vein distensibility index as a predictor of intraoperative fluid responsiveness during tidal volume challenge in patients undergoing elective surgery under general anaesthesia: A cross-sectional 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 Agathiyan 
Designation  Post Graduate student 
Affiliation  Maulana Azad Medical college and associated hospitals. 
Address  Department of Anaesthesiology and Intensive care ,B L Taneja Block, Maulana Azad Medical College and Associated Hospitals,New delhi-110002

Central
DELHI
110002
India 
Phone  8807264988  
Fax    
Email  agathiyanagathiyan8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Munisha Agarwal 
Designation  Director professor and Head of Department 
Affiliation  Maulana Azad Medical College 
Address  Department of Anesthesiology and Intensive care room no 308 maulana Azad medical college and associated lok nayak hospital,New Delhi,India,central delhi-110002

Central
DELHI
110002
India 
Phone  9968604216  
Fax    
Email  munisha.agarwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Agathiyan  
Designation  post graduate student 
Affiliation  Maulana Azad Medical college  
Address  Department of anesthesiology and intensive care ,Maulana Azad medical college and associated lok nayak hospital,New Delhi,India,central delhi-110002

Central
DELHI
110002
India 
Phone  8807264988  
Fax    
Email  agathiyanagathiyan8@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and Lok Nayak Hospital, 2, Bahadur Shah Zafar Marg,near Delhi Gate,Balmiki Basti,New Delhi-110002, India 
 
Primary Sponsor  
Name  Maulana Azad medical college and lok nayak hospital 
Address  Department of Anaesthesiology and intensive care ,BL taneja block, Maulana Azad Medical College and associated hospitals,new delhi-110002 
Type of Sponsor  Government medical college 
 
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 Agathiyan   Maulana Azad Medical College  Department of Anaesthesiology and intensive care BL taneja block, Maulana Azad Medical College and associated hospitals,new delhi-110002
Central
DELHI 
08807264988

agathiyanagathiyan8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana azad medical college and associated hospital institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: C00-D49||Neoplasms, (3) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (4) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (5) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (6) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients of American society of anesthesiologists physical status I,II
2.Patients who experience 20 to 40 % decrease in systolic blood pressure at induction . 
 
ExclusionCriteria 
Details  1.Patients with history of recurrent cardiac
arrythymia or significant heart and pulmonary
disease
2.Patients with left ventricle systolic dysfunction.
3.BMI more than 30 kg/m2
4.Preoperative use of beta blockers
5.Use of beta blockers, vasopressors, inotropes before or during tidal volume challenge test 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in percentage of internal jugular vein distensibility index during tidal volume challenge for prediction of fluid responsiveness in patients undergoing elective surgery under general anaesthesia  Baseline (before tidal volume challenge), at one minute after tidal volume challenge, 2 minute after tidal volume challenge, 12 minute after tidal volume challenge (after fluid administration) 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in percentage of (a)stroke volume index, (b) cardiac index & (c) stroke volume variation for prediction of fluid responsiveness during tidal volume challenge test   Baseline (before tidal volume challenge), at one minute after tidal volume challenge, 2 minute after tidal volume challenge, 12 minute after tidal volume challenge (after fluid administration) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   03/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Anaesthetic care regarding fluid therapy is crucial in preventing perioperative hypovolaemia or hypervolaemia, both of which are recognized factors contributing to increased morbidity and prolonged hospital stay. Intraoperative fluid management is crucial for hemodynamic stability, and predicting fluid responsiveness is essential for optimal patient outcomes. Fluid responsiveness can be predicted using both invasive and non-invasive methods. The invasive approaches include arterial pulse pressure and systolic pressure variation, pulse contour analysis, and central venous pressure. Non-invasive techniques comprise of passive leg raise test, inferior vena cava ultrasound, tidal volume challenge test, end-expiratory occlusion test, bioimpedance, bioreactance, and echocardiography. 

Tidal volume challenge (TVC)has been observed to accurately predict fluid responsiveness in mechanically ventilated patients in operating room. Prediction of fluid responsiveness using tidal volume challenge test has been studied on the basis of changes in cardiac output and stroke volume variation. The measurement involves insertion of invasive catheter which has its own technical challenges.  Recently, non- invasive monitoring of these parameters using thoracic bioimpedance has been found to reliably predict cardiac output and stroke volume variation in comparison to invasive techniques. However, it has cost implications. Sonographic assessment of internal jugular vein distensibility index (IJVDI) has recently been observed to correlate with fluid responsiveness. It is a safe and easy non-invasive technique used for hemodynamic monitoring. We hypothesize that changes in IJVDI will be able to predict fluid responsiveness in accordance with changes in cardiac index /stroke volume variation during tidal volume challenge test. Hence we aim to evaluate the internal jugular vein distensibility index as a predictor of intraoperative fluid responsiveness during tidal volume challenge in patients undergoing elective surgery under general anaesthesia. The study will be conducted in the department of anaesthesiology ,Maulana azad medical college and associated lok nayak hospital,new delhi.

 
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