| CTRI Number |
CTRI/2026/03/105162 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Subclavian and IVC collapsibility index to predict drop in blood pressure in obese patients after administering general anesthesia |
|
Scientific Title of Study
|
Comparative assessment of Subclavian vein versus Inferior
Vena Cava diameter and collapsibility index for predicting post induction
hypotension in obese patients undergoing elective surgeries under general
anaesthesia: 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 |
Parul Sharma |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesia, IPD block, AIIMS Bathinda, Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9928619187 |
| Fax |
|
| Email |
ps731515@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopal Krishan Jalwal |
| Designation |
Associate Proffessor |
| Affiliation |
AIIMS, Bathinda |
| Address |
IPD building, Department of Anesthesiology, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gopal Krishan Jalwal |
| Designation |
Associate Proffessor |
| Affiliation |
AIIMS, Bathinda |
| Address |
IPD building, Department of Anesthesiology, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia, AIIMS Bathinda |
| Address |
Department of Anesthesia, AIIMS Bathinda, Punjab, 151001, 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 Gopal Jalwal |
AIIMS Bathinda |
Department of Anesthesia, IPD block, AIIMS Bathinda, Punjab, India
Bathinda
PUNJAB |
7838939833
gopaljalwal@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, |
|
|
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 |
Patients with a BMI greater than or equal to 25 kg per meter square posted for elective surgical procedures |
|
| ExclusionCriteria |
| Details |
Patient refusal to consent
Pregnant females
Patients with moderate to severe hepatic, renal or respiratory disease
Patients with hypotension with systolic BP less than 90 mm of Hg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the predictive ability of pre-anaesthetic measurement of SCV and IVC diameter and CI to predict post GA induction hypotension |
To compare the predictive ability of pre-anaesthetic measurement of SCV and IVC diameter and CI to predict post GA induction hypotension at every minute for first 5 minutes, then every 2 minutes for for next 20 minutes and then every 5 minutes till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess success rates of SCV & IVC measurement using USG
To evaluate time taken for ultrasonographic measurement of IVC & SCV
To assess total amount of vasopressors required, if administered |
time taken for USG scanning in seconds or minutes noted after measurement
amount of vasopressors used with name & amount in milligram or microgram during intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
12/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
After Institutional Ethics Committee approval, written informed consent will be obtained from patients. Demographic data, diagnosis, fasting hours, BMI, and comorbidities will be recorded in a patient proforma.In the preoperative area, ultrasound guided measurements of maximum and minimum diameters of the subclavian vein (SCV) and inferior vena cava (IVC) will be taken three times each in supine patients during spontaneous normal breathing. These will be performed by a qualified anesthesiologist using a portable color Doppler ultrasound machine (Model Edge II, FUJIFILM Sonosite Inc, USA).For SCV, a high frequency linear transducer will be placed perpendicular to the clavicles long axis in the supine position, scanning the lateral third of the clavicle for a short axis view. Patients breathe normally, and minimum (dSCVmin) and maximum (dSCVmax) diameters at end expiration and inspiration will be measured in M mode during the same cycle.For IVC, a curved transducer will be placed subxiphoid with the pointer cephalad, moved right and cranial for a long axis view entering the right atrium. Pulse wave Doppler differentiates IVC from aorta. Minimum (dIVCmin) and maximum (dIVCmax) diameters at end inspiration and expiration will be measured in M mode. Mean values from three readings calculate collapsibility index (CI) as (Maximum diameter minus minimum diameter times 100 divided by maximum diameter).Time from probe placement to measurement and feasibility (ability to visualize and measure) will be noted. Data collected via case record form.In the operating theater, standard ASA monitors (ECG, pulse oximetry, NIBP) record baseline heart rate, NIBP, and SpO2. General anesthesia induction uses midazolam 005 mg/kg IV, fentanyl 2 mcg/kg IV, propofol 2 mg/kg IV, vecuronium 01 mg/kg IV; doses noted. The inducing anesthesiologist is blinded to preoperative findings. Loss of consciousness confirmed by vocal response/jaw thrust/eyelash reflex.Vitals monitored continuously; NIBP every 1 minute for 5 minutes, then every 2 minutes for 20 minutes, then every 5 minutes. Postinduction hypotension defined as MAP below 65 mmHg or over 20 percent drop from baseline. Hypotensive episodes treated with fluids/vasopressors at discretion; number and duration noted.Primary objective: Compare diagnostic accuracies of SCV/IVC diameters and CI for predicting postinduction hypotension in obese patients undergoing elective surgery. |