| CTRI Number |
CTRI/2024/03/063597 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measurement of blood flow indices in patients undergoing surgery |
|
Scientific Title of Study
|
Feasibility and accuracy of the descending thoracic aorta velocity time integral in predicting fluid responsiveness in patients undergoing major non-cardiac surgery- A prospective observational 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 Ananya Satapathy |
| Designation |
Post Graduate student |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No. 409, Academic Block, AIIMs Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8249425289 |
| Fax |
|
| Email |
ananyas1698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No. 409, Academic Block, AIIMs Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No. 409, Academic Block, AIIMs Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar 751019, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Satyajeet Misra |
| Address |
Room No 409,Academic Block
AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar 751019 |
| Type of Sponsor |
Other [Self] |
|
|
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 Satyajeet Misra |
AIIMS Bhubaneswar |
Department of Anesthesiology and Critical Care
Room No 409, Academic Block
Sijua, Patrapada
Bhubaneswar 751019
Khordha
ORISSA |
9438884048
misrasatyajeet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, in ASA physical status I-III undergoing major non-cardiac surgery under general endotracheal anaesthesia will be included in this study. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give consent.
2. ASA grade IV and beyond.
3. Patients undergoing emergency surgery.
4. Patients undergoing head and neck surgery.
5. Patients undergoing airway surgery.
6. Patients undergoing neurosurgery.
7. Patients with known inferior vena cava thrombosis or features of raised intra-abdominal pressures.
8. Patients undergoing laparoscopic surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility of the suprasternal window for measuring changes in velocity time integral in patients undergoing major non-cardiac surgery with general endotracheal anaesthesia. |
Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in stroke volume/cardiac output after a modified PLR.
2. Changes in stroke volume/cardiac output after volume expansion.
2. Correlation of the DTA VTI with LVOT VTI |
Preoperative and Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/03/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Predicting fluid responsiveness is of critical importance in patients undergoing major non-cardiac surgery. Though there a variety of methods such as static and dynamic predictors of preload responsiveness, there are many limitations to each. The velocity time integral in the aorta reflects stroke volume/cardiac output. The descending thoracic aortic flows are well aligned with Doppler through the suprasternal window. Although commercial Doppler monitors are present which assess the VTI across the ascending aorta, there are no previous studies that have used 2D ultrasound for interrogating DTA flows for assessment of changes in the flow velocities/VTI. The advantage of the 2D ultrasound for interrogation of the DTA is that the artery can be visualized and Doppler can be exactly aligned with the vessel to get the best flow velocities. This is in contrast to the commercial Doppler monitors where there is no direct visualization of the aorta and the Doppler signals are obtained through a hit and trial approach. The aim of this study will be to assess the feasibility of obtaining flow velocities across the DTA using the 2D Phased array probe from the suprasternal window in intubated patients undergoing major non-cardiac surgery. The secondary aims of the study will be to measure the accuracy of the DTA measurements by correlating it with LVOT VTI measurements, and to evaluate whether the modified PLR can be used intraoperatively to predict fluid responsiveness and whether the DTA VTI obtained with 2D ultrasound will be able to differentiate fluid responders from non-responders. Fluid administration will be clinician driven in this study. |