| 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
|
|
|
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
|
|
|
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. |