| CTRI Number |
CTRI/2025/01/079066 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Collapsibility of neck veins to Assess Fluid Levels in the body and Its Link to Lactate Levels in blood |
|
Scientific Title of Study
|
Use of Bedside Ultrasonography to Measure Internal Jugular Vein Collapsibility in
Estimating Intravascular Volume Status and its Correlation with Serum Lactate levels. |
| 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 Ananya Mishra |
| Designation |
Junior Resident |
| Affiliation |
Raipur Institute of Medical Sciences,Raipur,Chhattisgharh |
| Address |
Resident Room,ground floor,Main Hospital Building,Raipur Institute of Medical Sciences,Raipur,Chhattisgarh
RIMS Knowledge Park
Raipur
CHHATTISGARH
492101
India |
| Phone |
8889886493 |
| Fax |
|
| Email |
vini.ananya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Abhishek Bharadwaj |
| Designation |
Assistant Professor |
| Affiliation |
Raipur Institute of Medical Sciences,Raipur,Chhattisgharh |
| Address |
Faculty Room,Third floor OT,Main Hospital Building,Raipur Institute of Medical Sciences,Raipur,Chhattisgarh-492101.
Raipur
CHHATTISGARH
492101
India |
| Phone |
8860272013 |
| Fax |
|
| Email |
bharadwaj.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya Mishra |
| Designation |
Junior Resident |
| Affiliation |
Raipur Institute of Medical Sciences,Raipur,Chhattisgharh |
| Address |
Resident Room,ground floor,Main Hospital Building,Raipur Institute of Medical Sciences,Raipur,Chhattisgarh
RIMS Knowledge Park
Raipur
CHHATTISGARH
492101
India |
| Phone |
8889886493 |
| Fax |
|
| Email |
vini.ananya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Raipur Institute of Medical Sciences,Raipur,Chhattisgarh,India-492101 |
|
|
Primary Sponsor
|
| Name |
Raipur Institute of Medical Sciences |
| Address |
Near MM Funcity, Bhansoj Road,Raipur, Chhattisgarh-492101 |
| Type of Sponsor |
Private 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 Ananya Mishra |
Raipur Institute of Medical Sciences,Raipur,Chhattisgarh-492101. |
Department of Anaesthesiology and Critical Care,Critical care Unit,Ground Floor,Main Hospital Building,Raipur Institute of Medical Sciences,Raipur,Chhattisgarh-492101.
Raipur
CHHATTISGARH |
8889886493
vini.ananya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Raipur Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, (2) ICD-10 Condition: X088||Exposure to other specified smoke,fire and flames, (3) ICD-10 Condition: K922||Gastrointestinal hemorrhage, unspecified, (4) ICD-10 Condition: D500||Iron deficiency anemia secondary to blood loss (chronic), (5) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (6) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified, (7) ICD-10 Condition: J189||Pneumonia, unspecified organism, (8) ICD-10 Condition: B949||Sequelae of unspecified infectiousand parasitic disease, (9) ICD-10 Condition: T149||Unspecified injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 18-65 years.
2.Patients admitted to the critical care unit requiring assessment of intravascular volume
status. |
|
| ExclusionCriteria |
| Details |
1.Participants of age less than 18 years and more than 65 years.
2.presence of thrombus in IJV, history of previous IJV cannulation.
3.Those who are not willing to participate.
4. Patients with cardiac diseases, renal diseases,Diabetic ketoacidosis,alcohol intoxication,mitochondrial diseases, pregnancy,radiotherapy or surgeries or mass of the neck and chest.
5.Patients on mechanical ventilation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the correlation between internal jugular vein collapsibility, measured using
bedside ultrasonography, and serum lactate levels as markers of intravascular volume
status. |
15 minutesBefore fluid resuscitation,15 minutes after fluid resuscitation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the agreement between internal jugular vein collapsibility & traditional
methods of volume assessment, such as mean arterial pressure.
To evaluate the diagnostic accuracy of internal jugular vein collapsibility in identifying
hypovolemia & volume overload.
To identify any potential limitations or challenges associated with the use of internal
jugular vein collapsibility as a marker of intravascular volume status & its correlation
with serum lactate levels.
survival of the the patient |
15 minutes Before fluid resuscitation,15 minutes after fluid resuscitation,survival at 5 days or at the time of shifting the patient out of ICU. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
29/01/2025 |
| 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) |
Closed to Recruitment of Participants |
|
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
|
This research question aims to investigate the relationship between internal jugular vein collapsibility, assessed using bedside ultrasonography, and serum lactate levels as markers of intravascular volume status and tissue perfusion. By examining the correlation between these variables, the study seeks to determine the potential utility of internal jugular vein collapsibility as a non-invasive indicator of intravascular volume status and its association with tissue perfusion.This thesis aims to evaluate the use of bedside ultrasonography to measure internal jugular vein collapsibility in estimating intravascular volume status and its correlation with serum lactate levels. By investigating the relationship between these variables, this study seeks to contribute to the existing literature on non-invasive methods for volume assessment and enhance our understanding of the clinical implications of bedside ultrasonography in fluid management. |