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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  
Name  Address 
Nil   
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  divyakandan126238@gmail.com

  6. 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.

  7. 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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