| CTRI Number |
CTRI/2025/10/096024 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To have effective weaning by incorporating diaphragm ultrasound parameters with clinical parameters of weaning from ventilator and prevent mortality and morbidity associated with re intubation |
|
Scientific Title of Study
|
A randomized controlled trial comparing the weaning success in mechanically ventilated patients meeting RSBI and clinical criteria with and without diaphragm ultrasonography (DUS) |
| 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 Ajay Sood |
| Designation |
Professor and head department of anaesthesia IGMC Shimla |
| Affiliation |
IGMC Shimla |
| Address |
Department of Anaesthesia, block D floor 2 IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418028130 |
| Fax |
|
| Email |
ajay_5644@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Sood |
| Designation |
Professor and head department of anaesthesia IGMC Shimla |
| Affiliation |
IGMC Shimla |
| Address |
Department of anaesthesia block D floor 2IGMC Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418028130 |
| Fax |
|
| Email |
ajay_5644@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Sood |
| Designation |
Professor and head department of anaesthesia IGMC Shimla |
| Affiliation |
IGMC Shimla |
| Address |
Department of anaesthesia block d floor 2IGMC Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418028130 |
| Fax |
|
| Email |
ajay_5644@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Igmc shimla |
| Address |
Department of anaesthesia Igmc Shimla Himachal Pradesh PIN code 171001 |
| 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 |
| Shreya jain |
IGMC Shimla Himachal pradesh |
GICU Department of anaesthesia BLOCK D FLOOR 2
Shimla
HIMACHAL PRADESH |
8729031031
Shreyaalkajain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diaphragm ultrasonography (DUS) |
Diaphragm excursion (DE) and diaphragm thickness fraction (DTF) duration of study 9 months |
| Intervention |
Dr Ajay Sood |
Professor and head department of anaesthesia IGMC shimla Himachal Pradesh phone no 9418028130 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in GICU of dept. of Anaesthesia IGMC Shimla and are on mechanical ventilator with following parameters
1. Normal performance status before disease onset ( per- illness frailty score less than 3)
2. Who are mechanically ventilated for at lest 24 h
3. With satisfactory clinical weaning parameters such as the ability to tolerate a spontaneous breathing trial (SBT) for 1 h
4. Stable haemolytic or on minimal and single vasopressin ,afebrile in the last 24 hours, with minimal tracheo bronchial secretions and effective cough response will be invluded |
|
| ExclusionCriteria |
| Details |
1. Patient with neuromuscular disorder
2. Patient with pneumothorax
3. Preexisting diaphragmatic palsy
4. Who underwent thoracic and abdominal surgeries
5. Where ultrasound is not possible due to wound dressings |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weaning success is better in patients meeting Rapid shallow breathing index(RSBI) and clinical criteria with diaphragm ultrasonography (DUS) |
To check for reintegration rate within 24 hours |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="0"
Months="9"
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
|
Weaning patients from ventilation has always been a challenging task and wearing failure , re intubation are associated with increased risk of morbidity and mortality.Diaphragm is the major respiratory muscle and its proper functioning is necessary for spontaneous breathing Considering diaphragm excursion and diaphragm thickness fraction along with clinical criteria and RSBI before weaning patients from ventilator has proven to decrease re intubation rates in some studies |