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CTRI Number  CTRI/2021/08/035444 [Registered on: 05/08/2021] Trial Registered Prospectively
Last Modified On: 28/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective comparative study 
Study Design  Other 
Public Title of Study   An Observational study to compare the clinical outcomes of Ventilator Associated Events among COVID-19 and non COVID ICU patients. 
Scientific Title of Study   A Prospective comparative study on the clinical outcomes of Ventilator Associated Events among COVID-19 and non COVID ICU patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Susan Philip 
Designation  DrNB critical care medicine resident  
Affiliation  Lilavati Hospital and Research Centre 
Address  Department of critical care medicine Lilavati hospital and research centre Bandra reclamation road Bandra West Mumbai

Mumbai
MAHARASHTRA
400050
India 
Phone  9946617252  
Fax    
Email  susanphilip89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Conrad Rui Vas 
Designation  Chief Intensivist  
Affiliation  Lilavati Hospital and Research Centre 
Address  Department of critical care medicine Lilavati hospital and research centre Bandra reclamation road Bandra west Mumbai

Mumbai
MAHARASHTRA
400050
India 
Phone  9820125932  
Fax    
Email  conradruivas@lilavatihospital.com  
 
Details of Contact Person
Public Query  
Name  Dr Susan Philip 
Designation  DrNB critical care medicine resident  
Affiliation  Lilavati Hospital and Research Centre 
Address  Department of critical care medicine Lilavati hospital and research centre Bandra reclamation road Bandra west Mumbai

Mumbai
MAHARASHTRA
400050
India 
Phone  9946617252  
Fax    
Email  susanphilip89@gmail.com  
 
Source of Monetary or Material Support  
Lilavati hospital and research centre Bandra reclamation road Bandra west Mumbai Pin-400050 
 
Primary Sponsor  
Name  Lilavati hospital and research centre 
Address  Lilavati hospital and research centre Bandra reclamation road Bandra west Mumbai pin- 400050 
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 Susan Philip  Lilavati hospital and research centre  ICU Department of critical care medicine Bandra reclamation road Bandra west Mumbai pin- 400050
Mumbai
MAHARASHTRA 		 9946617252

susanphilip89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EC-BHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All patients who are above 18 years old and are admitted to the ICU and require mechanical ventilation for more than 2 days 
 
ExclusionCriteria 
Details  Patients on ECMO, ventilated for less than 48 hours, on NIV, who do not acheive stable ventilator settings after intubation or those who receives mechanical ventilation for more than 24 hours before ICU admission 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measured will be the rates of VAEs.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes include ICU mortality, duration of mechanical ventilation, successful extubation and tracheostomy.
 		 4 weeks 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   10/08/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   All ICU patients admitted to Lilavati hospital and research centre ICU during the study period , who are on mechanical ventilator and satisfies the inclusion criteria will be included in the study.Patients who do not acheive stable ventialtor settings after intubation or dies within 3 days of mechanical ventilation will be excluded. A data collection form will be prepared and each patient selected to be included in the study will be screened  and monitored according to the data collection form . A set of routine investigations will be performed and special investigations like blood urine and tracheal culture will be done when needed. Patients will be monitored daily from the date of inclusion in the study till extubation or 28 days, whichever is earlier. VAEs will be identified using the new NHSN VAE surveillance algorithm.  
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