| CTRI Number |
CTRI/2025/10/095940 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Subclavian -Infraclavicular Axillary vein collapsibility index as predictor of hypotension after subarachnoid block in lower limb surgeries in geriatric patients. |
|
Scientific Title of Study
|
Subclavian -Infraclavicular Axillary vein collapsibility index as predictor of hypotension after subarachnoid block in lower limb surgeries in geriatric 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 |
Vandana rana |
| Designation |
Assistant professor |
| Affiliation |
Graphic era institute of medical sciences |
| Address |
OT Complex
Department of anaesthesiology
4th floor
GEIMS
Dhoolkot mafi, Dehradun
Dehradun
UTTARANCHAL
248007
India |
| Phone |
8650603901 |
| Fax |
|
| Email |
drvandana.rana07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana rana |
| Designation |
Assistant professor |
| Affiliation |
Graphic era institute of medical sciences |
| Address |
OT Complex
Department of anaesthesiology
4th floor
GEIMS
Dhoolkot mafi, Dehradun
Dehradun
UTTARANCHAL
248007
India |
| Phone |
8650603901 |
| Fax |
|
| Email |
drvandana.rana07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana rana |
| Designation |
Assistant professor |
| Affiliation |
Graphic era institute of medical sciences |
| Address |
OT Complex
Department of anaesthesiology
4th floor
GEIMS
Dhoolkot mafi, Dehradun
Dehradun
UTTARANCHAL
248007
India |
| Phone |
8650603901 |
| Fax |
|
| Email |
drvandana.rana07@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT Complex
Department of anaesthesiology
4th floor
GEIMS
Dhoolkot mafi, Dehradun OT Complex
Department of anaesthesiology
4th floor
GEIMS
Dhoolkot mafi, Dehradun graphic era institute of medical sciences
Dhoolkot mafi , Dehradun, Uttarakhand
248007
India
|
|
|
Primary Sponsor
|
| Name |
Graphic era institute of medical sciences |
| Address |
Graphic era institute of medical sciences
Dehradun , Uttarakhand , India
248007 |
| 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 Vandana Rana |
graphic era institute of medical sciences |
OT Complex,
Department of Anaesthesiology
4TH FLOOR OT
Dhoolkot mafi , dehradun 248007
Dehradun
UTTARANCHAL |
8650603901
drvandana.rana07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GEU-GEIMS ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z538||Procedure and treatment not carried out for other reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologist physical status I , II , III. |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate.
2.Requirement for vasopressors to maintain a mean arterial blood pressure ( MAP) greater than 65mmhg, baseline MAP less than 70 mmhg.
3.Presence of major peripheral vascular disease , severe valvular disease , right sided heart failure , respiratory distress.
4. Hepatic or renal disorders .
Absolute contraindication to spinal block. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determine the ability of SVCI to predict hypotension after sub-arachanoid block (SAB) in geriatric patients.
To calculate the sensitivity and specificity of SVCI in predicting hypotension.
|
Every 2 minutes after SAB. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To investigate the relationship between SVCI & haemodynamic changes.
To identify the risk factors for hypotension after SAB.
|
Every 2 minutes after SAB |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
22/10/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Ultrasonography of right subclavian vein (SCV) will be performed in supine position to visualise the SCV or infraclavicular axillary vein(AV) in short axis view. Short axis view of the vein will be obtained while the patient is breathing normal (spontaneous breathing) and while breathing deep (deep breathing) . Minimum and maximum diameters of the SCV or AV (dSCVmin and dSCVmax, respectively will be assessed in M-mode at a medium sweep speed and collapsibility index (CI) will be calculated as (3). (dSCVmax-dSCVmin)/dSCVmax × 100
|