| CTRI Number |
CTRI/2025/07/090182 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the Role of Breathing Muscles thickness in removing patient from ventilator. |
|
Scientific Title of Study
|
Assessment And Comparison of The Association of Diaphragmatic Thickness Fraction and Parasternal Intercostal Muscle Thickness Fraction
With Weaning Failure from Mechanical Ventilation.
|
| 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 Sumit Ray |
| Designation |
Head & Medical Director |
| Affiliation |
Holy Family Hospital |
| Address |
Department Of Critical Care Medicine
Holy Family Hospital, Okhla Road New Delhi-110025
South
DELHI
110025
India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Ray |
| Designation |
Head & Medical Director |
| Affiliation |
Holy Family Hospital |
| Address |
Department Of Critical Care Medicine
Holy Family Hospital, Okhla Road New Delhi-110025
South
DELHI
110025
India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Ray |
| Designation |
Head & Medical Director |
| Affiliation |
Holy Family Hospital |
| Address |
Department Of Critical Care Medicine
Holy Family Hospital, Okhla Road New Delhi-110025
South
DELHI
110025
India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Holy Family Hospital
Okhla Road
New Delhi-110025
India |
|
|
Primary Sponsor
|
| Name |
Dr Sumit Ray |
| Address |
Department Of Critical Care Medicine
Holy Family Hospital, Okhla Road New Delhi-110025
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Sumit Ray |
Holy Family Hospital |
Department of Critical Care Medicine
Holy Family Hospital
Okhla Road
New Delhi-110025
South
DELHI |
09810614433
drsray67@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Holy Family Hospital Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years
2.Patients on mechanical ventilation for more than
24 hours.
3.Fulfilling weaning criteria
4.Adequate cough, absence of excessive tracheobronchial secretion, resolution of underlying critical illness for which the patient is intubated
5.The patient is alert and cooperative, without sedation |
|
| ExclusionCriteria |
| Details |
1.History of diaphragm paralysis, spinal cord injury higher than T8
2.Chronically on domiciliary BiPAP support
3.Neuromuscular diseases,
4.Pregnancy
5.Pneumothorax, pneumomediastinum, thoracostomy, chest tube or chest injuries that prevent ultrasound
6.Pleural lesions or pleurodesis
7.Previous history of failed extubation or weaning.
8. Left ventricular ejection fraction less than 40%
9.H/o Chronic lung disease with cor pulmonale (Interstitial Lung disease, Chronic Obstructive Pulmonary Disease)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weaning Success:
Successful extubation with no need for ventilatory support within 48 hours post-extubation. |
Within 48 hours post-extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIl |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
01/08/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 at Holy Family Hospital, New Delhi will evaluate weaning readiness in ICU patients on mechanical ventilation for over 24 hours. After ethical approval and informed consent, eligible patients will undergo assessments, including diaphragm thickness and intercoastal muscle measurements, using ultrasound during a spontaneous breathing trial (SBT). Diaphragm thickening fraction (TFdi) and intercostal muscle thickening fraction (TFic) will be calculated. The Rapid Shallow Breathing Index (RSBI) will also be recorded. Treating intensivists, blinded to these findings, will make extubation decisions, with weaning success defined as sustained extubation without support for 48 hours. |