| CTRI Number |
CTRI/2024/10/075857 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between two different methods for deciding when to remove a breathing tube from patients in the ICU. |
|
Scientific Title of Study
|
Addition Of Ultrasound Guided Excursion Time Index To Conventional Weaning Criteria Vs Conventional Weaning Criteria Alone For Extubation In ICU Patients -A Comparative 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 Sunil Chawla |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9915530033 |
| Fax |
|
| Email |
drchawla30@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jonny Dhawan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main ICU, Sri Guru Ram Das Institute of Medical
Sciences and Research
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9915926761 |
| Fax |
|
| Email |
jonnydhawan074@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshdeep Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8196892896 |
| Fax |
|
| Email |
arshdeepk816@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jonny Dhawan |
Sri Guru Ram Das Institute of Medical Sciences and Research |
Main ICU, First Floor, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001
Amritsar
PUNJAB |
9915926761
jonnydhawan074@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD 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 |
| Comparator Agent |
Normal extubation criteria |
it consist serial Arterial Blood Gas and Rapid Shallow breathing index |
| Intervention |
Ultrasound |
it will be used to check diaphragm mobility |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Patients with Neuromuscular disorders
3. Diaphragm paralysis
4. Pneumothorax
5. Massive pleural effusion
6. Tracheostomised |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess whether the diaphragm ultrasound based ET index can be used as another parameter for the weaning process
|
from the time when patients needs extubation till 72 hours post extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Role of ultrasound guided diaphragm function for weaning outcome.
2. To compare APACHE II score with number of days a patient is ventilated.
|
from the time when patients needs extubation till 72 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/10/2024 |
| 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)
|
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
|
Introduction: Ventilator weaning is an essential step in the care of ICU patients,
involving the gradual removal of mechanical ventilatory support. Determining the
correct timing for extubation in mechanically ventilated patients is a significant
challenge for intensivists. If USG-guided ETI proves to be superior to conventional
weaning criteria, it could enhance patient outcomes by reducing the incidence of failed
extubations, minimizing the need for reintubation, and shortening ICU length of stay.
Therefore, comparing these two approaches is crucial for advancing our understanding
of extubation readiness and optimizing the care of ICU patients undergoing
mechanical ventilation.
Aims and Objectives: Aim of the study is to Compare USG guided excursion time
index alongwith conventional weaning criteria for successful extubation in ICU
patients. Objective of the study is to determine if USG-guided excursion time index
can aid in successful ICU weaning and to compare extubation success rates using this
index alongside conventional weaning criteria versus conventional criteria alone.
Methodology: The study is proposed to be conducted from July 2024 to December
2025 at the Department of Anaesthesiology and Critical Care, Sri Guru Ram Das
Institute of Medical Sciences & Research, Amritsar. It will focus on critically ill
patients undergoing mechanical ventilation and supposed ready for weaning in the
intensive care unit. Mechanically ventilated patients will be randomly divided into two
groups. Group A will be extubated using conventional weaning criteria and Group B
will be extubated using conventional weaning criteria along with USG guided
excursion time index.
Outcome/Significance:. Both groups will be compared for extubation success and
extubation failure, defined as patients reintubated within 48 hours. Primary Outcome
of the study will be to assess whether the diaphragm ultrasound-based ETI can be
used as an additional parameter in the weaning process. |