| 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
|
|
|
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
|
|
|
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. |