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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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