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CTRI Number  CTRI/2024/01/061329 [Registered on: 10/01/2024] Trial Registered Prospectively
Last Modified On: 26/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Lung Ultrasound Score or HACOR score- Which is the best score to predict the possibility of weaning failure during extubation from mechanical ventilator 
Scientific Title of Study   Comparison of Lung Ultrasound Score versus HACOR score in predicting weaning outcome in patients with high risk for extubation failure 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rathish M 
Designation  DM Postgraduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai .

Chennai
TAMIL NADU
600116
India 
Phone  9442733636  
Fax    
Email  rathishmanimohan@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Renuka MK 
Designation  Head of the Department 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai .

Chennai
TAMIL NADU
600116
India 
Phone  8056126336  
Fax    
Email  renuka.mk@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Rathish M 
Designation  DM Postgraduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai .

Chennai
TAMIL NADU
600116
India 
Phone  9442733636  
Fax    
Email  rathishmanimohan@yahoo.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India 
Type of Sponsor  Research institution and hospital 
 
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 Rathish M  Sri Ramachandra Medical Center and Hospital  Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU 		 9442733636

rathishmanimohan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil as it is observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All intubated patients more than 18 years of age who meet the criteria for High risk for extubation failure 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Comparison of HACOR score versus Lung Ultrasound Score in predicting weaning outcome from mechanical ventilation in patients with high risk for extubation failure
 		 After 60 minutes of spontaneous breathing trial.
 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the predictors of weaning failure.
 		 After 60 minutes of spontaneous breathing trial 
 
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)   18/01/2024 
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="0"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rathishmanimohan@yahoo.com].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 19-02-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background : 

With an increase in the number of patients requiring mechanical ventilation and a shortage of intensivists, primary care physicians are also tasked with weaning. Weaning strategies are either dependent on complex ventilatory parameters or ultrasound measurements or are subjective.There is a need for objective scores that are easy to perform and are less resource-intensive.

Lung ultrasound score has high sensitivity in predicting weaning outcome but its complex , subjective and are not widely available so by comparing the sensitivity of HACOR score which is easy to perform and less resource intensive we can incorporate the use of HACOR score as a predictor of weaning outcome if this score has good sensitivity as Lung Ultrasound score.

 
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