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CTRI Number  CTRI/2024/01/061139 [Registered on: 05/01/2024] Trial Registered Prospectively
Last Modified On: 09/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Comparative 
Study Design  Other 
Public Title of Study   Comparison of Internal Jugular vein Collapsibility and IVC Collapsibilty with CVP measurement. 
Scientific Title of Study   Comparative Analysis of IJV Collapsibility Index vs. IVC Collapsibility Index by Point of Care Ultrasound with Direct CVP Estimation: A Comparative 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  Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  BJGMC and SGH, Pune 
Address  Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001

Pune
MAHARASHTRA
411001
India 
Phone  08983741147  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  BJGMC and SGH, Pune 
Address  Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001


MAHARASHTRA
411001
India 
Phone  08983741147  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  BJGMC and SGH, Pune 
Address  Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001


MAHARASHTRA
411001
India 
Phone  08983741147  
Fax    
Email  bjsujit@gmail.com  
 
Source of Monetary or Material Support  
Sassoon General Hospital, Pune 
 
Primary Sponsor  
Name  Sujit Kshirsagar 
Address  Dept of Trauma care centre, BJGMC and SGH, Pune 
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 Sujit Kshirsagar  Sassoon General Hospital, Pune  Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001
Pune
MAHARASHTRA 
8983741147

bjsujit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, B.J. Govt. Medical College, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T149||Unspecified injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients between age 18 to 65 yrs.
2. Patients admitted in intensive care unit.
 
 
ExclusionCriteria 
Details  1. Patients who had a history of radiotherapy or surgery to the neck or chest
2. Patients with pulmonary hypertension, severe tricuspid regurgitation
3. Patients with previous or active upper extremity deep venous thrombosis
4. Pregnant women will be excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to assess the correlation between IJV-CI, IVC-CI and direct CVP measurements.  At the time of admission in intensive care unit. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Nil 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   10/01/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Introduction: -  Hemodynamic assessment is a critical aspect of patient care, particularly in situations where accurate estimation of central venous pressure (CVP) is essential for guiding clinical management. Traditional methods of CVP measurement involve invasive procedures that can lead to complications and are often time-consuming. In recent years, point-of-care ultrasound (POCUS) has emerged as a valuable tool for non-invasive hemodynamic assessment. Specifically, the collapsibility indices of the internal jugular vein (IJV) and inferior vena cava (IVC) have gained attention as reliable indicators of CVP. This comparative study aims to evaluate the effectiveness of IJV collapsibility index and IVC collapsibility index, as determined through POCUS, in estimating CVP when compared with direct CVP estimation methods.

Material & methods: - This single-centre, observational, comparative study designed to assess whether IJV measurements would correlate with that of IVC measurements and invasively monitored CVP in critically ill patients.

 
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