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CTRI Number  CTRI/2023/08/057130 [Registered on: 31/08/2023] Trial Registered Prospectively
Last Modified On: 21/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Indirect Measurement of volume status in body 
Scientific Title of Study   Ultrasound reference values for inferior vena cava diameter and collapsibility index in critical care patients - a prospective observational 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  Dr INIYAVAN S 
Designation  Second year junior resident 
Affiliation  B J Medical college and civil hospital Asarwa Ahmedabad 
Address  F3 block First floor Department of Anaesthesiology B.J Medical college and civil hospital Asarwa

Ahmadabad
GUJARAT
380016
India 
Phone  9159305151  
Fax    
Email  iniyavans2396@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SMITA R ENGINEER 
Designation  Professor 
Affiliation  B J Medical college and civil hospital Asarwa Ahmedabad 
Address  F3 block 1st floor Department of anaesthesiology B.J Medical college and Civil Hospital Asarwa

Ahmadabad
GUJARAT
380016
India 
Phone  9825504943  
Fax    
Email  seng_90@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr SMITA R ENGINEER 
Designation  Professor 
Affiliation  B J Medical college and civil hospital Asarwa Ahmedabad 
Address  F3 block 1st floor Department of Anaesthesiology B J Medical college and civil hospital Asarwa


GUJARAT
380016
India 
Phone  9825504943  
Fax    
Email  seng_90@yahoo.com  
 
Source of Monetary or Material Support  
Government of Gujarat 7th floor 7th block Health and Family Welfare Department New Sachivalaya Gandhinagar Gujarat 
 
Primary Sponsor  
Name  Government of Gujarat 
Address  7th floor 7th block Health and family welfare department New sachavalay Gandhinagar Gujarat 
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 INIYAVAN S  B.J Medical college and civil Hospital  3rd floor Trauma Intensive care unit B.J Medical college and civil Hospital Asarwa
Ahmadabad
GUJARAT 
9159305151

iniyavans2396@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee B. J. Medical College & Civil Hospital, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:

1. Patients/relative willing to consent for the study
2. Age :18 to 85 years
3. Either gender
4. Patient on non-invasive or invasive mode of ventilation
5. Accessible epigastric region for ultrasonography
 
 
ExclusionCriteria 
Details  Exclusion Criteria:

1. Patients with ischemic heart disease (IHD), LV dysfunction or decompensated heart failure, any valvular heart diseases, cardiomyopathy
2. Chronic lung disease ,liver diseases
3. Age <18years
4. Patient/relative refusal
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure changes in IVC diameter at end inspiration & at end expiration   at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate IVC diameter correlation with demographic details
2. To calculate IVC collapsibility index as percentage
 
at baseline 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   07/09/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

              In severely ill patients and emergencies the accurate estimation of intravascular volume is vital for guiding fluid therapy. Clinically this can be extremely difficult. Traditionally central venous pressure (CVP) is used as a guide in fluid management since it serves as a physiologic estimate of the intravascular fluid volume and the mean right atrial pressure. It is a particularly important parameter to measure in critically-ill patients who may require fluid resuscitation. However, CVP measurement requires invasive central venous catheter placement which is time consuming and may be associated with a number of complications like arterial puncture, venous air embolism, hemo/pneumothorax.

            The IVC is a large, compliant vein that carries deoxygenated blood into the right atrium. Its size and shape correlate strongly with the CVP. As it is highly compliant, the size of the IVC varies with intravascular pressure; it collapses during inspiration and dilates during expiration. In healthy subjects breathing spontaneously, cyclic changes in thoracic pressure may result in collapse of the IVC diameter of approximately 50%. The dimensions and respirophasic changes of the IVC can easily be studied by ultrasound. Ultrasonography is a quick, noninvasive, portable, easy and safe procedure for the examination of the inferior vena cava (IVC)., being a safe, nonionizing, noninvasive, portable and accessible imaging modality.

          Many studies have confirmed the association between the size of the IVC and collapsibility index (CI) with the right-sided cardiac hemodynamics and pressure. CI as a simple guide to right review hence atria pressure has also been investigated and found to be reliable.

    This study aimed to assess the diameter and CI of the IVC among criticall ill patients who require non-invasive or invasive ventilator support in ICU.

 

 
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