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CTRI Number  CTRI/2026/01/100108 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational study to assess the correlation of weight change and length of stay in ICU and mortality in patients on mechanical ventilator support. 
Scientific Title of Study   Correlation of weight change over one week of ICU admission measured on integrated weighing scales in ICU beds and the outcome of critically ill patients with need of mechanical ventilator. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol version 1.0, dated 27 Jul 2025  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhawana Sharma 
Designation  Senior Consultant  
Affiliation  Medanta The Medicity Gurugram  
Address  Institute of Critical Care and Anesthesia, 2nd Floor ICU 7and 8,Medanta The Medicity Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  9891665459  
Fax    
Email  dr.bhawna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhawana Sharma 
Designation  Senior Consultant  
Affiliation  Medanta The Medicity Gurugram  
Address  Institute of Critical Care and Anesthesia, 2nd Floor ICU 7 and 8,Medanta The Medicity Sector 38 GurugramMedanta The Medicity Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  9891665459  
Fax    
Email  dr.bhawna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhawana Sharma 
Designation  Senior Consultant  
Affiliation  Medanta The Medicity Gurugram  
Address  Institute of Critical Care and Anesthesia, 2nd Floor ICU 7 and 8,Medanta The Medicity Sector 38 GurugramMedanta The Medicity Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  9891665459  
Fax    
Email  dr.bhawna@gmail.com  
 
Source of Monetary or Material Support  
Medanta The Medicity ,Sector 38 Gurugram 122001 
 
Primary Sponsor  
Name  Medanta The Medicity 
Address  Institute of Critical Care and Anesthesia, 2nd Floor ICU 7 and 8,Medanta The Medicity Sector 38 GurugramMedanta The Medicity Sector 38 Gurugram 
Type of Sponsor  Private hospital/clinic 
 
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 Bhawana Sharma  Medanta The Medicity   Medanta The Medicity ,Institute of critical care and anaesthesia , second floor ICU 7 and 8 Sector 38 , Gurugram
Gurgaon
HARYANA 		 9891665459

dr.bhawna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z759||Unspecified problem related to medical facilities and other health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients who need mechanical ventilator support 
 
ExclusionCriteria 
Details  Pregnant patients
Patients on palliative care
Patients on end of life care 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration on mechanical ventilator
weaning
length of stay in ICU
cumulative fluid balance
PF ratio
Glassgow coma scale
nutritional status
hospital mortality

 		 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Trend in acute organ dysfunction
residual acute organ dysfunction
pressure sores.
 		 12 months 
 
Target Sample Size   Total Sample Size="89"
Sample Size from India="89" 
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)   09/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 11-12-2026 and end date provided 11-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary    The aim of this study is to  correlate weight change over one week of ICU admission measured on integrated weighing scales on ICU beds and outcome of critically ill patients with the need of mechanical ventilator. Prediction of  clinical outcome parameters  will be studied. Fluid balance quantification is not completely reliable and subjective. Using beds with integrated weighing scales can be an  objective method that is easy , cost effective, reproducible and more reliable for fluid balance quantification.  
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