| CTRI Number |
CTRI/2025/09/094308 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Role of subclavian collapsibility index in post spinal hypotension in geriatric patient undergoing below umbilical surgery |
|
Scientific Title of Study
|
Role of subclavian vein collapsibility index in predicting post spinal hypotension in geriatric patients undergoing below umbilical surgery - 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 Divya Bharathy K |
| Designation |
1st year PG student |
| Affiliation |
|
| Address |
Room .no ,106 department of anaesthesiology sri manakula vinayagar medical college and hospital kalitheerthalkuppam puducherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
9940308079 |
| Fax |
|
| Email |
divyakandan126238@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dilip chandar |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room .no ,106 department of anaesthesiology sri manakula vinayagar medical college and hospital kalitheerthalkuppam puducherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dilip chandar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room .no ,106 department of anaesthesiology sri manakula vinayagar medical college and hospital kalitheerthalkuppam puducherry
Pondicherry PONDICHERRY 605107 India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital kalitheerthalkuppam puducherry 605107 |
|
|
Primary Sponsor
|
| Name |
Divya Bharathy K |
| Address |
Room .no ,106 department of anaesthesiology sri manakula vinayagar medical college and hospital kalitheerthalkuppam puducherry 605107 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Divya Bharathy K |
Sri manakula vinayagar medical college and hospital |
No :105
Department of anaesthesia Pondicherry PONDICHERRY |
9940308079
divyakandan126238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ethics committe |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 60 years
ASA I&II |
|
| ExclusionCriteria |
| Details |
Refusal to participate
Known cardiac, hepatic, or renal dysfunction
Contraindications to spinal anesthesia
Hemodynamically unstable patients preoperatively
Patients with neck or thoracic deformities precluding adequate ultrasound assessment of the
subclavian vein |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Collapsibility index of subclavian vein |
0 minutes to 0:30 mins of spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure |
0,5,10,15,20,25,30 mins |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
25/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - divyakandan126238@gmail.com
- For how long will this data be available start date provided 30-07-2025 and end date provided 30-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The study will be conducted in the Department of Anesthesiology at Sri Manakula Vinayagar Medical College and Hospital as a prospective observational study. All patients will undergo a preoperative examination to check eligibility based on inclusion and exclusion criteria. After explaining the study procedure, informed written consent will be obtained. Patient demographic data such as age, gender, height, weight, and BMI will be recorded. Pre-medication with tablet pantoprazole 40 mg and tablet alprazolam 0.5 mg will be given the night before surgery, and patients will remain nil per oral overnight. On the day of surgery, eligible patients meeting ASA fasting guidelines will be enrolled in the study.
Preoperative ultrasound examination will be done using a Sono Site M-Turbo portable machine with curvilinear and linear probes. The right subclavian vein will be assessed with a linear probe placed in the sagittal plane at the deltopectoral triangle. The subclavian vein collapsibility index (CI) will be calculated as the difference between maximum and inspiratory diameters divided by the maximum diameter, expressed as a percentage. CI measurements will be taken during spontaneous and deep inspiration. Baseline vitals will be recorded before spinal anesthesia is administered per standard protocol. Post-spinal, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate will be recorded every five minutes for 30 minutes. Hypotension, defined as SBP < 90 mmHg, MAP < 60 mmHg, or a 20% fall from baseline, will be managed with IV fluids and vasopressors.
This study aims to evaluate the role of the subclavian vein collapsibility index (SCVCI) in predicting intravascular volume status and the risk of post-spinal hypotension. The subclavian vein is easier to visualize with ultrasound, especially in obese patients and those undergoing abdominal surgeries. Early prediction of hypotension using SCVCI may aid in optimizing perioperative fluid management and improving hemodynamic stability. Additionally, SCVCI assessment could help predict hospital stay duration and recovery, potentially leading to better outcomes in geriatric patients.
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