| CTRI Number |
CTRI/2023/06/053732 [Registered on: 09/06/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the role of ultrasonography of diaphragm in liberation of critical patients from ventilator. |
|
Scientific Title of Study
|
To assess the utility of Diaphragmatic Ultrasonography in determining weaning outcome in mechanically ventilated patients – A prospective observational study |
| Trial Acronym |
DRSBI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No 1 Version no 1 dated 22 Dec 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vipin Sukumaran |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
Narayana Hrudayala Multispeciality hospital, Mysore |
| Address |
Department of Critical Care medicine, Narayana Hrudayalaya Multispeciality hospital, CAH/1, 3rd Phase, Devanur, Mysore
Mysore
KARNATAKA
570019
India |
| Phone |
07420065560 |
| Fax |
|
| Email |
vipinsukumaran83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAVEEN S |
| Designation |
HEAD OF DEPARTMENT CRITICAL CARE MEDICINE |
| Affiliation |
Narayana Hrudayala Multispeciality hospital, Mysore |
| Address |
Department of Critical Care medicine, Narayana Hrudayalaya Multispeciality hospital, CAH/1, 3rd Phase, Devanur, Mysore
Mysore
KARNATAKA
570019
India |
| Phone |
9448922780 |
| Fax |
|
| Email |
naveen.s.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Vipin Sukumaran |
| Designation |
DrNB Critical Care Medicine Resident |
| Affiliation |
Narayana Hrudayala Multispeciality hospital, Mysore |
| Address |
Department of Critical Care medicine, Narayana Hrudayalaya Multispeciality hospital, CAH/1, 3rd Phase, Devanur, Mysore
Mysore
KARNATAKA
570019
India |
| Phone |
07420065560 |
| Fax |
|
| Email |
vipinsukumaran83@gmail.com |
|
|
Source of Monetary or Material Support
|
| NARAYANA HRUDAYALAYA MULTISPECIALITY HOSPITAL, DEVANUR, MYSORE, KARNATAKA |
|
|
Primary Sponsor
|
| Name |
NARAYANA HRUDAYALAYA MULTISPECIALITY HOSPITAL |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, NARAYANA HRUDAYALAYA MULTISPECIALITY HOSPITAL, DEVANUR, MYSORE, PIN 570019 |
| 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 VIPIN SUKUMARAN |
NARAYANA HRUDAYALAYA MULTISPECIALITY HOSPITAL |
DEPARTMENT OF CRITICAL CARE MEDICINE,NARAYANA HRUDAYALA MULTISPECIALITY HOSPITAL, CAH/1, 3rd Phase, Devanur, MYSORE, PIN 570019
Mysore
KARNATAKA |
07420065560
vipinsukumaran83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NARAYANA HEALTH ACADEMICS ETHICS 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age above 18yrs.
2. Patients who have received mechanical ventilation for more than 24 hrs and who are ready to be weaned (to get spontaneous breathing trial) after satisfying the conventional criteria for the same will be enrolled in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient’s with Diaphragmatic Palsy
2.Patient’s with Pneumothorax
3.Post thoracotomy Patients
4.Patient’s with flail Chest
5.Patient’s with Neuromuscular diseases
6.Breach in skin preventing DUS examinations in subcostal area
7. Pregnant Patients
8.Refusal of consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the utility of Diaphragmatic rapid shallow breathing index (D-RSBI) in determining weaning outcomes in mechanically ventilated patients |
2 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare D-RSBI with DTF in determining weaning outcomes in mechanically ventilated patients |
2 DAYS |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2023 |
| Date of Study Completion (India) |
14/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Diaphragmatic rapid shallow breathing index (D-RSBI) is a novel index which is used to assess diaphragmatic function in mechanically ventilated patients. There are various studies in the past which has evaluated the utility of diaphragmatic ultrasonography in predicting weaning of patients from mechanical ventilation. We conducted a prospective observational study regarding the utility of diaphragmatic ultrasonography in predicting weaning outcome in mechanically ventilated patients. We came to the conclusion that Diaphragmatic Rapid shallow breathing index (D-RSBI) is a better predictor than RSBI is predicting weaning outcome in mechanically ventilated patients. All the diaphragmatic parameters had acceptable predictive value in determining weaning outcome in mechanically ventilated patients. |