| CTRI Number |
CTRI/2025/08/093818 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
A study on ICU patients to assess whether lung ultrasound score can help predict breathing success after removal from ventilator |
|
Scientific Title of Study
|
Comparison Of Lung Ultrasound B Line Score With Oxygenation Indices In Predicting Successful Weaning From Mechanical Ventilation: 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 |
Dr Nelwin Jerald Sabu |
| Designation |
Senior Resident |
| Affiliation |
BLK Max Superspeciality Hospital, Rajendra Place, New Delhi |
| Address |
Centre for Critical Care, BLK Max Superspeciality Hospital, Pusa Road, Rajendra Place, New Delhi
New Delhi
DELHI
110005
India |
| Phone |
9539173820 |
| Fax |
|
| Email |
nelwinjerald@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Pande |
| Designation |
Principal Director and HOD- Critical Care |
| Affiliation |
BLK Max Superspeciality Hospital, Rajendra Place, New Delhi |
| Address |
BLK Max Superspeciality Hospital, Pusa Road, Rajendra Place, Delhi-110005
New Delhi
DELHI
110005
India |
| Phone |
9810536268 |
| Fax |
|
| Email |
rajeshmaitree2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nelwin Jerald Sabu |
| Designation |
Senior Resident |
| Affiliation |
BLK Max Superspeciality Hospital, Rajendra Place, New Delhi |
| Address |
Centre for Critical Care, BLK Max Superspeciality Hospital, Pusa Road, Rajendra Place, New Delhi
New Delhi
DELHI
110005
India |
| Phone |
9539173820 |
| Fax |
|
| Email |
nelwinjerald@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
BLK Max Superspeciality Hospital Rajendra Place New Delhi |
| Address |
Centre for Critical Care, BLK Max Superspeciality Hospital, Pusa Road, Rajendra Place, New Delhi-110005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Nelwin Jerald Sabu |
BLK Max Superspeciality Hospital, Rajendra Place, New Delhi |
Centre for Critical Care, 3rd Floor, BLK Max Superspeciality Hospital, Pusa Road, Rajendra Place, New Delhi-110005. India
New Delhi
DELHI |
9539173820
nelwinjerald@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLK Max Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years
2. Mechanically ventilated patients via an endotracheal tube
3. Duration of mechanical ventilation for more than or equal to 48 hours
4. Planned for a spontaneous breathing trial or extubation
|
|
| ExclusionCriteria |
| Details |
1. Patients with multiple cranial nerve palsies.
2. Patients with neurological diseases such as Myasthenia gravis, Muscular
Dystrophy, Motor Neuron Disease.
3. Tracheostomized patients.
4. End-of-life care patients.
5. Patients with terminal cancer.
6. Extremely critical moribund patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the predictability of successful weaning with LUS B line score guidance versus oxygenation indices guidance weaning (PaO2/FiO2 ratio,
Oxygenation index, Oxygen saturation index) in intubated and mechanically ventilated patients |
1.Baseline (within 24 hours of intubation): Hemodynamics, ventilator settings, ABG, lung ultrasound B-line score.
2.Pre-SBT (before Spontaneous Breathing Trial): Repeat above parameters
3.Within 48 hours of extubation: Outcome assessment – weaning success or failure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the cut-off values (scores for successful weaning/failed weaning) for each of the parameters (LUS B Line score, P/F ratio, OI, and OSI).
To determine the correlation between the LUS B line score with each of the oxygenation indices.
|
1.Baseline (within 24 hours of intubation): Hemodynamics, ventilator settings, ABG, lung ultrasound B-line score.
2.Pre-SBT (before Spontaneous Breathing Trial): Repeat above parameters
3.Within 48 hours of extubation: Outcome assessment – weaning success or failure. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/09/2025 |
| 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="0"
Months="8"
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 is a prospective observational study conducted in the adult ICU of a tertiary care hospital to evaluate the correlation between lung ultrasound B line score and oxygenation indices in patients undergoing weaning from mechanical ventilation. The study aims to identify cut-off values of lung ultrasound B line score, P/F ratio, spO2/FiO2 ratio, and oxygenation saturation index to predict successful or failed weaning. Data will be collected at 2 time points: Within 24 hours of intubation and prior to spontaneous breathing trial. Patient will be assessed for either weaning success or weaning failure. A total of 90 patients will be assessed over a period of 8 months |