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CTRI Number  CTRI/2025/10/096138 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Using ultrasound to see how well a patient can breathe on their own before removing breathing machine (ventilator) support in ICU patients  
Scientific Title of Study   Accuracy of cardiorespiratory ultrasound assessment for predicting weaning failure during spontaneous breathing trial: An 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  Priyanka Dhar 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College and associated hospitals 
Address  Lady Hardinge Medical College and associated hospitals Department of Anaesthesia, 5th floor academic building Shahid Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  9101515925  
Fax    
Email  prnkdhar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Anil Kumar 
Designation  Professor 
Affiliation  Lady Hardinge Medical College and associated hospitals 
Address  Lady Hardinge Medical College and associated hospitals Department of Anaesthesia, 5th floor academic building Shahid Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  8084660100  
Fax    
Email  drkumaranil@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Priyanka Dhar 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College and associated hospitals 
Address  Lady Hardinge Medical College and associated hospitals Department of Anaesthesia, 5th floor academic building Shahid Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  9101515925  
Fax    
Email  prnkdhar@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi , India 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Department of Anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi India 110001 
Type of Sponsor  Government medical college 
 
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 
Dr Priyanka Dhar  Lady Hardinge Medical College  Department of Anaesthesia Shahid Bhagat Singh Marg New Delhi Lady Hardinge Medical College and associated hospitals Shahid Bhagat Singh Marg New Delhi
Central
DELHI 
09101515925

prnkdhar@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R918||Other nonspecific abnormal findingof lung field,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age group more than equal to 18 years age of either gender who are on invasive mechanical ventilation for more than 48 hours and are eligible for spontaneous breathing trial (SBT).
2. Patients meeting the following criteria for SBT:
a. Resolution of the acute phase of the underlying condition that led to mechanical ventilation
b. Adequate oxygenation (PaO2/FiO2 more than equal to 200, PEEP less than equal to 8 cm H2O, FiO2 less than equal to 0.4)
c. Hemodynamic stability (no vasopressors or low-dose vasopressors)
d. Adequate mental status (able to follow commands)
e. Temperature less than 38.5°C
f. Adequate cough reflex
 
 
ExclusionCriteria 
Details  1. Any pregnant patient
2. Patient having rib fractures or flail chest or severe chest wall deformities
3. Any patient with cervical spine injury
4. Patients having pneumothorax (false lowering of LUS scores-suggesting better aeration than exists)
5. Poor ultrasound image views
6. Documented paradoxical movement of diaphragm or hemi-diaphragm on ultrasound
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To predict accuracy (of cardiorespiratory ultrasound assessment for weaning failure during spontaneous breathing trial.   T1- During SBT on PS 8 cm H20, PEEP less than equal to 5 cm H20- Week 0 (Day of SBT initiation)
T2-During SBT on T-piece Week 0 (same session, following T1)
T3-After SBT- Within 1 hour post-SBT (Week 0)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Predictive accuracy of individual ultrasound modalities (cardiac, lung, & diaphragm) for weaning failure.
2. Predictive accuracy of conventional weaning parameters (RSBI, P0.1) for weaning failure.
 
T1- During SBT on PS 8 cm H20, PEEP less than equal to 5 cm H20- Week 0 (Day of SBT initiation)
T2-During SBT on T-piece Week 0 (same session, following T1)
T3-After SBT- Within 1 hour post-SBT (Week 0)
 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   26/10/2025 
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="3"
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  
This prospective observational cohort study will be conducted in Lady Hardinge Medical College, New Delhi. Adult patients (more than equal to 18 years) on invasive mechanical ventilation for more than 48 hours who meet standard criteria for a spontaneous breathing trial (SBT) will be enrolled after informed consent. Each participant will undergo comprehensive cardiorespiratory ultrasound assessment—including echocardiographic, lung, and diaphragmatic evaluation—at three stages: during pressure-support ventilation, during SBT on a T-piece, and after SBT completion. Conventional weaning parameters such as the rapid-shallow-breathing index and airway occlusion pressure (P0.1) will also be recorded. Patients will be followed for 48 hours post-extubation to determine weaning success or failure. The diagnostic performance of ultrasound parameters will be analyzed using sensitivity, specificity, predictive values, and area under the ROC curve, with statistical significance set at p < 0.05.

Importance of the Research
Weaning failure remains a major determinant of prolonged ventilation, ICU stay, and mortality in critically ill patients. Conventional indices like the RSBI often fail to identify patients at risk because they assess only ventilatory mechanics and ignore cardiac or diaphragmatic contributions. This study addresses an important gap by evaluating an integrated ultrasound approach that simultaneously examines the heart, lungs, and diaphragm to predict weaning outcomes. If validated, this bedside, non-invasive method could enhance clinical decision-making, reduce extubation-related complications, and improve resource utilization in critical care settings.
 
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