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CTRI Number  CTRI/2020/06/026185 [Registered on: 26/06/2020] Trial Registered Prospectively
Last Modified On: 26/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   CORRELATION OF TWO METHODS TO ASSESS THE VOLUME STATUS IN CRITICALLY ILL PATIENTS. 
Scientific Title of Study   CORRELATION OF ULTRASOUND GUIDED IVC COLLAPSIBILITY INDEX WITH CENTRAL VENOUS PRESSURE TO ASSESS THE VOLUME STATUS IN INTENSIVE CARE UNIT PATIENTS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranvinder Kaur 
Designation  Professor 
Affiliation  ABVIMS Dr RML Hospital 
Address  Department of Critical Care Medicine 2nd floor Trauma building ABVIMS Dr RML Hospital New Delhi

Central
DELHI
110001
India 
Phone  9717932744  
Fax    
Email  rsindhoo@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Ranvinder Kaur 
Designation  Professor 
Affiliation  ABVIMS Dr RML Hospital 
Address  Department of Critical Care Medicine 2nd floor Trauma building ABVIMS Dr RML Hospital New Delhi

Central
DELHI
110001
India 
Phone  9717932744  
Fax    
Email  rsindhoo@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Anjane Sree 
Designation  PG Resident 
Affiliation  ABVIMS Dr RML Hospital 
Address  Department of Anesthesiology 3rd floor PGI building ABVIMS Dr RML Hospital New Delhi

Central
DELHI
110001
India 
Phone  8148103365  
Fax    
Email  anjanesree@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS AND DR.RML HOSPITAL DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE 
 
Primary Sponsor  
Name  Department of Anesthesiology 
Address  3rd floor PGI Building ABVIMS Dr RML Hospital New Delhi 
Type of Sponsor  Government medical college 
 
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 Anjane Sree  ABVIMS and Dr RML Hospital  Department of Critical Care Medicine 2nd floor Trauma building ABVIMS and Dr RML Hospital New Delhi
Central
DELHI 
8148103365

anjanesree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ABVIMS Dr RML Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I999||Unspecified disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patient >18 yrs of age with a central venous catheter terminating in distal SVC.
2. BMI 18-30 Kg/m2. 
 
ExclusionCriteria 
Details  1. Clinical signs of elevated abdominal pressure.
2. Moderate to severe tricuspid regurgitation.
3. Patients in whom the supine position is contraindicated. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Measurement of ultrasound guided collapsibility index and CVP.  At time of admission to ICU 
 
Secondary Outcome  
Outcome  TimePoints 
Measurement of ultrasound guided collapsibility index and CVP.  After 24 hours of admission to ICU 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   27/06/2020 
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="0"
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)?  

Brief Summary  

Bedside assessment of intravascular volume status in critically ill patients is challenging. Fluid management impacts systemic perfusion and may influence the risk of organ failure and mortality. Clinicians often use invasive hemodynamic monitoring as an adjunct to information gathered from the physical examination and laboratory evaluation to arrive at a fluid management strategy. A non-invasive and economical technique like ultrasound in the ICU helps to approach regarding hemodynamic status and treatment of the critically ill patients. The physiologic principle  underlying IVC collapsibility index is that during spontaneous breathing, inspiration leads to negative intrathoracic pressure, which in turn leads to three additional effects. Collapsibility of the inferior vena cava has been found to be useful in monitoring response to therapy as well as assisting in ongoing resuscitation by providing means to measure CVP non-invasively.

Informed consent will be obtained from all the patients, and they will be assured that the identity of the respondents will be kept anonymous. 

Before collection of USG data, study ultra-sonographers will be blinded to CVP monitoring. Bedside ultrasound images will be obtained in a systematic fashion with the patient supine to determine the dimensions and collapsibility of the IVC. 

Immediately following the ultrasound image acquisition, study personnel will obtain a simultaneous recording of the CVP waveform from the distal lumen of the central venous catheter . The CVP will be uniformly measured from a recording at end expiration with the patient supine and the pressure transducer having been zeroed at the mid-thoracic position. A patient with CVP of less than 8 cmH2O will be considered as hypovolemic. The patients with CVP between 8–12 cmH2O will be considered as euvolemic and patients having CVP > 12 cmH2O will be considered as hypervolemic.

Statistical Analysis will be performed using standard statistical methods.

 
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