| CTRI Number |
CTRI/2025/06/088176 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of Using ultrasound in the patients in icu to improve the prediction of extubation |
|
Scientific Title of Study
|
Study of Ultrasonographic assessment of diaphragmatic parameters as predictors of weaning success in the intensive care unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Racky Jose |
| Designation |
Junior resident |
| Affiliation |
Goa medical college |
| Address |
Goa medical college
Anaesthesia department
Division-anaesthesia
Room number 4
North Goa
GOA
403202
India |
| Phone |
7907837382 |
| Fax |
|
| Email |
rakhi.jose07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohini Bhat Pai |
| Designation |
Associate Professor |
| Affiliation |
Goa medical college |
| Address |
Goa medical college
Anaesthesia department
Division-anaesthesia
Room number 4
North Goa
GOA
403202
India |
| Phone |
7741866436 |
| Fax |
|
| Email |
rohinivpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohini Bhat Pai |
| Designation |
Associate Professor |
| Affiliation |
Goa medical college |
| Address |
Goa medical college
Anaesthesia department
Division-anaesthesia
Room number 4
North Goa
GOA
403202
India |
| Phone |
7741866436 |
| Fax |
|
| Email |
rohinivpai@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Racky Jose |
| Address |
Goa medical college
Anaesthesia department
|
| 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 |
| Racky Jose |
Goa medical college |
Room no.29
Department of anaesthesia
North Goa
GOA |
7907837382
rakhi.jose07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
)subjected to invasive mechanical ventilation for at least 24 hours.
2)suitable for spontaneous breathing trial(SBT) according to ICU protocol by the ICU doctor’s team .
|
|
| ExclusionCriteria |
| Details |
) age more than 80 years old
2) primary diaphragmatic disease or trauma
3 undergone oesophageal and thoracic surgeries
4) pregnant women
5) electrolyte derangements and other correctable disorders
6)unstable haemodynamics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is successful weaning defined as no ventilator support for 48 hours post-extubation. Secondary outcomes include diaphragmatic ultrasound parameters (excursion and thickening fraction measured pre-extubation and immediately post-extubation), total ventilation duration, ICU stay, re-intubation incidence, and mortality as recorded. |
no ventilator support for 48 hours post-extubation followed up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes of the study explored the association between diaphragmatic weaning parameters & the Rapid Shallow Breathing Index (RSBI). A significant correlation was found between diaphragmatic excursion & RSBI, while no significant correlation was observed between diaphragmatic thickness fraction or the time to peak inspiratory amplitude of the diaphragm & RSBI. |
weaning success at 48 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
09/06/2025 |
| 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)
|
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 prospective observational study demonstrates that ultrasonographic assessment of diaphragmatic parameters, particularly diaphragmatic excursion combined with the rapid shallow breathing index, serves as a reliable predictor of weaning success in ICU patients. These metrics offer superior predictive value compared to other diaphragmatic measures, such as diaphragmatic thickness fraction and time to peak inspiratory amplitude.
|