| CTRI Number |
CTRI/2026/01/100066 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Fluid] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study aims to find a method to check whether patients undergoing lower limb surgeries have enough body fluid and compares two large veins to find out which gives more accurate results thus helping doctors to give right amount of fluid to prevent low blood pressure during surgery. |
|
Scientific Title of Study
|
To determine the predictive accuracy of subclavian vein collapsibility index for assessing intravascular volume status of patients undergoing lower limb surgeries: A prospective comparison of subclavian vein and inferior vena cava collapsibility index |
| 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 Aparna Sharma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical college, Shimla, Himachal Pradesh |
| Address |
Department of Anaesthesia,
Indira Gandhi Medical college,
Ridge Sanjauli road,
Lakkar Bazar,
Shimla, Himachal Pradesh.
171001
India
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418083224 |
| Fax |
|
| Email |
aparnasharmaraina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Sharma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical college, Shimla, Himachal Pradesh |
| Address |
Department of Anaesthesia,
Indira Gandhi Medical college,
Ridge Sanjauli road,
Lakkar Bazar,
Shimla, Himachal Pradesh.
171001
India
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418083224 |
| Fax |
|
| Email |
aparnasharmaraina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Jhagta |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical college, Shimla, Himachal Pradesh |
| Address |
Department of Anaesthesia,
Indira Gandhi Medical college,
Ridge Sanjauli road,
Lakkar Bazar,
Shimla, Himachal Pradesh.
171001
India
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8219344703 |
| Fax |
|
| Email |
garimajhagta20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Pradesh Government,
Shimla, Himachal Pradesh
171001
India |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical college |
| Address |
Ridge Sanjauli road, Lakkar bazar, Shimla, Himachal Pradesh
171001
India |
| 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 Garima Jhagta |
Indira Gandhi Medical college Shimla Himachal Pradesh |
Department of Anesthesia, Main OT complex, Indira Gandhi Medical college Shimla, 171001, Himachal Pradesh
Shimla
HIMACHAL PRADESH |
8219344703
garimajhagta20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S899||Unspecified injury of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
500ml fluid bolus |
500ml fluid bolus will be given over 10-15 minutes only in collapsing category of patients that is patients with inferior vena cava collapsibility index more than 50 percent .Repeat evaluation of IVC-CI and SCV-CI will be done 15 minutes after fluid administration. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lower limb orthopaedic surgeries in spinal anaesthesia
Patients in age group of 18 to 60 years weighing 50 to 80 kg with BMI less than 35 kg per meter square
Mean arterial pressure more than 65mmHg
ASA 1 and 2 physical status patients |
|
| ExclusionCriteria |
| Details |
Refusal to participate
Patients requiring vasopressors to maintain arterial blood pressure greater than 65mmHg
Cardiac disease
Implanted pacemaker
Morbid obesity
Respiratory distress
Autonomic nervous system disorders
Presence of major peripheral vascular disease
Portal hypertension
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate predictive accuracy of subclavian vein collapsibility index in non collapsing and collapsing groups of patients |
Assessment in non collapsing group at baseline and assessment in collapsing group at baseline and 15 minutes post fluid bolus. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate predictive accuracy of subclavian vein collapsibility index in collapsing group of patient after receiving a fluid bolus of 500ml |
15 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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 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
|
This is a prospective study which aims to evaluate the predictive accuracy of subclavian vein collapsibility index for assessing the intravascular volume status of patients undergoing lower limb surgeries in spinal anaesthesia and compare it with inferior vena cava collapsibility index. The primary objective of the study is to calculate the sensitivity, specificity, positive predictive value and negative predictive value of subclavian vein collapsibility index for intravascular volume assessment and the secondary objective is to assess the correlation between subclavian vein collapsibility index and inferior vena cava collapsibility index. Therefore the study seeks to establish whether subclavian vein collapsibility index is feasible and reliable alternative to inferior vena cava collapsibility index particularly in situations where inferior vena cava visualisation is difficult. |