| CTRI Number |
CTRI/2025/12/099457 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing Automated and Manual Heart Ultrasound Measurements in Adults with Septic Shock, |
|
Scientific Title of Study
|
CORRELATION BETWEEN AUTOMATED AND MANUAL ECHOCARDIOGRAPHIC MEASUREMENTS OF LEFT VENTRICULAR EJECTION FRACTION, VELOCITY TIME INTEGRAL, AND INFERIOR VENA CAVA DIAMETERS IN ADULT PATIENTS WITH SEPTIC SHOCK: A PROSPECTIVE OBSERVATIONAL STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BK RAO |
| Designation |
Emeritus Consultant and Advisor |
| Affiliation |
Sir Ganga Ram Hospital New Delhi |
| Address |
DR B K RAO
Institute of critical care medicine
SSB building 4th floor
Sir Ganga Ram Hospital Rajinder nagar
New Delhi
New Delhi
Central DELHI 110060 India |
| Phone |
9811177755 |
| Fax |
|
| Email |
drbkrao@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr BK RAO |
| Designation |
Emeritus Consultant and Advisor |
| Affiliation |
Sir Ganga Ram Hospital New Delhi |
| Address |
DR B K RAO
Institute of critical care medicine
SSB building 4th floor
Sir Ganga Ram Hospital Rajinder nagar
New Delhi Sir Ganga Ram Hospital New Delhi Central DELHI 110060 India |
| Phone |
9811177755 |
| Fax |
|
| Email |
drbkrao@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
ASHUTOSH KUMAR SINGH |
| Designation |
DrNB |
| Affiliation |
Sir Ganga Ram Hospital New Delhi |
| Address |
Dr Ashutosh kumar singh DrNB Trainee
senior resident room
Institute of critical care medicine
SSB building 4th floor
Sir Ganga Ram Hospital Rajinder nagar
New Delhi F1, Tower 12, Type IV
East Kidwai Nagar
New Delhi Central DELHI 110060 India |
| Phone |
7004940763 |
| Fax |
|
| Email |
kumardr.ashutosh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital
Rajindra Nagar
New Delhi-110060 |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital
Rajinder Nagar
New Delhi-110060 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr BK Rao |
Sir Ganga Ram Hospital New Delhi |
Department-Institute of critical care medicine/ counter I-IV
SSB building 4th floor.
Central DELHI |
09811177755
drbkrao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R031||Nonspecific low blood-pressure reading, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient in septic shock |
|
| ExclusionCriteria |
| Details |
Echocardiography not possible
Rapid ongoing intravenous infusion or boluses
Pregnancy
Structural heart disease
Atrial fibrillation / flutter / other dysrhythmia
Cardiac transplant, LVAD/ECMO support in situ
Post cardiac arrest
Failed to obtained consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find intraclass correlation coefficient between manual and automated measurement of left ventricular ejection fraction (LVEF), left ventricular outflow tract velocity time integral (LVOT-VTI) and inferior vena cava (IVC) collapsibility/ distensibility in adult patients with septic shock |
18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the limit of agreement of auto EF, VTI, & IVC collapsibility/distensibility measurements with manual measurements in adult patients with septic shock.
2. To determine the proportion of acquiring average-to-good images (analysable images) by an intensivist using auto tools in adult patients with septic shock.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/01/2026 |
| 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 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
|
Septic shock represents the most severe manifestation
of sepsis, characterized by profound circulatory, cellular, and metabolic
dysfunction leading to life-threatening organ failure. Point of care
ultrasound (POCUS) brought the cardiac ultrasound to the bed side, providing
relevant, accurate and reproducible information for diagnosis, therapy, and
monitoring. The POCUS echo exams remain heavily dependent on the operator skill
and experience. Use of Point Of Care Ultrasound (POCUS) in
critically ill patients have been recommended by various guidelines and forums
including Task force of the European Society of Intensive Care Medicine, Society of Critical Care Medicine. While doing
focused echocardiography, the intensivists is tasked with both the manual image
acquisition and its interpretation, which requires training and
experience. Advances in
artificial intelligence in echocardiography made it possible to use it as a
tool for automatic measurement of some cardiac and hemodynamic parameters.
Automatic echo tools can standardize the image
acquisition and their interpretation even in the hands of minimally trained
operator. Automation
tools in POCUS have been developed only for Left ventricle ejection fraction,
Left ventricle outflow tract velocity time integral, and inferior vena cava
diameters by Point of Care Ultrasound machines. The
present prospective observational study is planned to evaluate the correlation
between manual and automated measurement of left ventricular ejection
fraction (LVEF), left ventricular outflow tract velocity time integral (LVOT
VTI) and inferior vena cava (IVC) diameters in adult patients with septic
shock. |