| CTRI Number |
CTRI/2024/01/061284 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of ultrasound and echocardiography based parameters for successful removal of ventilator support in adult ICU patients |
|
Scientific Title of Study
|
Utility of ultrasound and echocardiography-based parameters for successful extubation in adult patients on mechanical ventilation: a prospective observational 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. Prakash S Shastri |
| Designation |
Senior Consultant and Vice Chairman |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital, Old Rajinder Nagar, Delhi
New Delhi DELHI 110060 India |
| Phone |
9818392246 |
| Fax |
|
| Email |
prakashshastri@live.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Prakash S Shastri |
| Designation |
Senior Consultant and Vice Chairman |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital, Old Rajinder Nagar, Delhi-110060
New Delhi DELHI 110060 India |
| Phone |
9818392246 |
| Fax |
|
| Email |
prakashshastri@live.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Prakash S. Shastri |
| Designation |
Senior Consultant and Vice Chairman |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital, Old Rajinder Nagar, Delhi-110060
New Delhi DELHI 110060 India |
| Phone |
9818392246 |
| Fax |
|
| Email |
prakashshastri@live.in |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Prakash SShastri |
| Address |
Sir Ganga Ram Hospital, Old Rajinder Nagar, Delhi-110060 |
| 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 |
| Dr Diksha Gaur |
Sir Ganga Ram Hospital |
Main ICU 4th floor SSRB New Building, Ganga Ram Hospital, Old Rajinder Nagar, Delhi-110060 Central DELHI |
9818392246
diksha.gaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to the ICU and on mechanical ventilation more than 48 hours and subjected to SBT during the study period will be enrolled |
|
| ExclusionCriteria |
| Details |
Post Cardiac arrest deemed not for resuscitation Failure to obtain consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the association of the suggested Ultrasound and echocardiography parameters with successful tracheal extubation |
48 hours post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)The incidence of failed extubation
b) length of stay (LOS) in ICU
c) hospital mortality
|
48 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/01/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Despite improvement in the quality of intensive care, the incidence of failed extubation is 5%–30%. Several indices have been used in the past to predict successful weaning and extubation. However, none of these indices have a good positive predictive value. Therefore, it is expected that the inclusion of ultrasound of the chest and heart would be successful in identifying the patients who will likely fail the weaning trial. Critical illness produces diaphragmatic dysfunction which can contribute to weaning failure. The inability of heart to cope with the increased load of work of breathing is also responsible for re-intubation. Therefore, we planned this study with the aim to evaluate the association of parameters derived from the ultrasound of the diaphragm, and from bedside echocardiography with successful extubation. Critically ill adult patients who are mechanically ventilated for more than 48 hours will be screened for the study. Patients who fulfill the “readiness to wean criteria†and initiated on spontaneous breathing trial will be enrolled. We intend to enroll 130 patients in the study. Diaphragmatic Ultrasound and Echocardiography will be performed during 30 minutes of Spontaneous Breathing Trial (SBT). Primary Outcome of the study is to calculate the Area under Receiver Operating Curves (AUROC), sensitivity and specificity of Diaphragm ultrasonography and ECHO- guided parameters for assessing their association with successful tracheal extubation. Secondary outcomes include incidence of successful extubation (defined as the ability to tolerate spontaneous breathing for 48 hours without need for endotracheal re- intubation), length of ICU stay and in-hospital mortality. Receiver Operator Curve (ROC) analysis will be done to determine optimal cut off values for each parameter. The AUROC, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the parameters obtained will be calculated to analyze their association with successful extubation. This being an observational study, extubation will be carried out as per the standard protocol and the investigators will not take part in that decision. |