| CTRI Number |
CTRI/2026/01/100687 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ultrasound guided diaphragmatic excursion ratio and ventilator -based criteria for weaning mechanically ventilated ICU patients |
|
Scientific Title of Study
|
Comparative study between the use of ultrasound guided diaphragmatic excursion ratio versus the ventilator criteria from weaning in mechanically ventilated patients in ICU. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saloni Shah |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
8485962408 |
| Fax |
|
| Email |
saloni24shah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit P Chauhan |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit P Chauhan |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya,
Vadodara, Gujarat , India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
| Type of Sponsor |
Private 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 Amit P Chauhan |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT |
9426368170
dramitchauhan85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Weaning off from mechanical ventilation through ultrasound guided diaphragmatic excursion ratio |
It is the ratio of diaphragmatic movement during spontaneous breathing during mechanical breathing |
| Comparator Agent |
Weaning off from mechanical ventilation using Ventilator criteria |
It refers to set of clinical,respiratory and physiological changes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients whose relatives are willing to sign informed consent
Male or Female patients more than 18 years of age
Respiratory failure requiring mechanical ventilation for more than 24 h
Meeting all of the following criteria for the SBT FiO2 less than 50% positive end-expiratory
pressure less than or eqal to 5 cmH2O respiratory rate less than or equal to 30 breaths/min PaO2 FiO2 ration more than 200 mmHg
hemodynamic stability in the absence of vasopressors
|
|
| ExclusionCriteria |
| Details |
Patient with neuromuscular disease and tracheostomy
Patients with diaphragm paralysis on either side were excluded
Patient with spinal cord injury higher than T8
Patient with arrhythmias and pregnancy were excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help us in weaning off in ICU based on usg criteria vs ventilator criteria |
Before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare accuracy of USG based criteria vs ventilator criteria in predicting success of weaning off from mechanical ventilation |
48 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/01/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
AIM The timing of weaning should be carefully considered to prevent adverse effects. Our goal is to look at the predictive values of DTF and DE in terms of extubation rate and to decide when the patient should be extubated for successful weaning in mechanically ventilated patients in ICU.
OBJECTIVES 1. To assess accuracy of USG based criteria in predicting success of weaning off from mechanical ventilation. 2. To compare accuracy of USG based criteria vs ventilator criteria in predicting success of weaning off from mechanical ventilation.
INCLUSION CRITERIA 1. Patients whose relatives are willing to sign informed consent 2. Male or Female patients more than 18 years of age. 3. Respiratory failure requiring mechanical ventilation for more than 24 h 4. Meeting all of the following criteria for the SBT: FiO2<50%, positive end-expiratory pressure ≤5 cmH2O, respiratory rate≤30 breaths/min, PaO2/FiO2>200 mmHg 5. hemodynamic stability in the absence of vasopressors.
EXCLUSION CRITERIA 1. Patient with neuromuscular disease and tracheostomy. 2. Patients with diaphragm paralysis on either side were excluded. 3. Patient with spinal cord injury higher than T8. 4. Patient with arrhythmias and pregnancy were excluded.
Site of Study: Department of anaesthesiology, Dhiraj Hospital, S.B.K.S.Medical Institute and research Centre, Piparia, Waghodia, Vadodara
Study Design: Prospective c o m p a r a t i v e study
Study Duration: The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or by whichever is earlier.
Outcome of study - This prospective study will help us to compare the efficacy of USG based criteria vs ventilator criteria in predicting success of weaning off IN MECHANICALLY VENTILATED PATIENTS IN ICU. |