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
|
|
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
|
|
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.
|