| 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
|
|
|
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
|
|
|
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
|
|
|
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. |