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CTRI Number  CTRI/2026/01/102303 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Change in Blood Volume Getting Pumped Out of the Heart Before and After Passively Raising the Legs of a Patient on Ventilator as a Predictor of Liberation from Ventilator in the Intensive Care Unit - A Prospective Observational Study 
Scientific Title of Study   Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) Change to Passive Leg Raise for Prediction of Extubation Failure in the Intensive Care Unit: 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  Vinayak S R 
Designation  Doctorate of National Board Registrar in Critical Care Medicine 
Affiliation  Aster Medcity, Kochi, Kerala 
Address  Aster Medcity Hospital, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027

Ernakulam
KERALA
682027
India 
Phone  8714228128  
Fax    
Email  vinayaksr2008@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anuroop Balagopal 
Designation  Senior Consultant, Critical Care Medicine 
Affiliation  Aster Medcity, Kochi, Kerala 
Address  Aster Medcity Hospital, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027

Ernakulam
KERALA
682027
India 
Phone  9447473376  
Fax    
Email  dranuroop.balagopal@asterhospital.in  
 
Details of Contact Person
Public Query
 
Name  Vinayak S R 
Designation  Doctorate of National Board Registrar in Critical Care Medicine 
Affiliation  Aster Medcity, Kochi, Kerala 
Address  Aster Medcity Hospital, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027

Ernakulam
KERALA
682027
India 
Phone  8714228128  
Fax    
Email  vinayaksr2008@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Vinayak S R 
Address  Aster Medcity, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027 
Type of Sponsor  Other [Other] 
 
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 
Vinayak S R  Aster Medcity, Kochi, Kerala  Department of Critical Care Medicine, 3rd Floor, Tower 1
Ernakulam
KERALA 
8714228128

vinayaksr2008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee, Aster Medcity, Kochi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: G00-G99||Diseases of the nervous system, (3) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
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  Patients who underwent extubation following a successful SBT and who had been on mechanical ventilation for more than 24 hours,
Stable oxygenation (FiO2 less than 0.5, PEEP less than or equal to 5 cm H2 O)
A respiratory rate of less than 30 breaths per minute,
An absence of fever,
Alert and cooperative,
Hemodynamically stable,
The absence of high doses of vasopressor therapy (requirement of norepinephrine more than 0.1 mcg per kg per min or equivalent vasopressor doses). 
 
ExclusionCriteria 
Details  Patients with spinal cord injuries above the T8 level,
Presence of significant cardiac arrhythmia,
Diaphragmatic paralysis,
ICU-acquired neuromyopathy,
Planned noninvasive ventilation (NIV) following extubation
Poor ultrasound windows.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate whether a percent change in Left ventricular Outflow Tract Velocity Time Integral following passive leg raise (PLR) (performed before SBT) predicts weaning failure   At any point following extubation during the stay in the Intensive Care Unit 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the predictive value of diaphragmatic ultrasound (Diaphragmatic Thickening Fraction & Diaphragmatic Excursion) for weaning failure  At any point following extubation during the stay in the Intensive Care Unit 
To identify independent predictors of failure using a binary logistic regression model  At any point following extubation during the stay in the Intensive Care Unit 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/02/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Background: Difficulty in weaning from mechanical ventilation occurs in a significant number of intensive care unit patients. While various indices exist, an integrated approach evaluating cardiac and diaphragmatic function may better predict outcomes. Cardiovascular dysfunction during a spontaneous breathing trial is a recognized cause of weaning failure. This study aims to evaluate if the dynamic response of the heart to a preload challenge can predict success.

Objectives: The primary objective is to evaluate the diagnostic accuracy of the percentage change in Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) following a Passive Leg Raise (PLR) as a predictor of successful extubation. Secondary objectives include evaluating the predictive value of diaphragmatic thickening fraction and diaphragmatic excursion, and any other independent variable in weaning from mechanical ventilator 

Methods: This is a prospective observational cohort study. Adult patients mechanically ventilated for at least 48 hours who meet standard criteria for a spontaneous breathing trial (SBT) will be included. Before the SBT, baseline LVOT VTI and diaphragmatic ultrasound measurements will be recorded in a semi-recumbent position. A PLR maneuver will be performed to calculate the percentage change in VTI. Patients will then undergo a standardized 120-minute SBT. Weaning success is defined as the absence of re-intubation or the need for non-invasive ventilation for 48 hours post-extubation.

Sample Size and Analysis: A sample size of 60 patients is planned, assuming a 50 percent weaning failure rate to provide 99 percent power to detect significant differences based on previous literature. Diagnostic accuracy will be assessed using Receiver Operating Characteristic (ROC) curves to determine optimal cut-off values. Logistic regression will be used to identify independent predictors of weaning failure.

 
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