FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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 
 
Details of Secondary Sponsor  
Name  Address 
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R031||Nonspecific low blood-pressure reading,  
 
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 interpretationwhich 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.


 
Close