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CTRI Number  CTRI/2023/09/057226 [Registered on: 04/09/2023] Trial Registered Prospectively
Last Modified On: 29/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Preoperative evaluation of collapsibility of large blood vessels like subclavian vein & inferior vena cava to predict blood pressure drop associated with spinal anaesthesia 
Scientific Title of Study   Preoperative evaluation of collapsibility Index- subclavian vein and inferior vena cava for predicting hypotension in spinal 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  Muthukumaran 
Designation  PG resident 
Affiliation  Sri Manakula Vinayagar Medical College And Hospital 
Address  Department of Anesthesiology, Sri manakula vinayagar medical college and hospital, madagadipet, kalitheerthalkuppam,puducherry-6050107
Department of Anesthesiology, Sri manakula vinayagar medical college and hospital, madagadipet, kalitheerthalkuppam,puducherry-6050107
Pondicherry
PONDICHERRY
6050107
India 
Phone  7010358123  
Fax    
Email  muthukumaransmv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dilip chandar D 
Designation  Associate professor 
Affiliation  Sri Manakula Vinayagar Medical College And Hospital 
Address  Department of Anesthesiology, First floor, Sri manakula vinayagar medical college and hospital, madagadipet, kalitheerthalkuppam,puducherry-6050107
Sri manakula vinayagar medical college and hospital, madagadipet, kalitheerthalkuppam,puducherry-6050107
Pondicherry
PONDICHERRY
6050107
India 
Phone  9993031202  
Fax    
Email  dilipchandar2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Muthukumaran 
Designation  PG resident 
Affiliation  Sri Manakula Vinayagar Medical College And Hospital 
Address  Department of Anesthesiology, Sri manakula vinayagar medical college and hospital, madagadipet, kalitheerthalkuppam,puducherry-6050107
Department of anaesthesiology, Sri manakula vinayagar medical college and hospital, madagadipet, kalitheerthalkuppam,puducherry-6050107
Pondicherry
PONDICHERRY
6050107
India 
Phone  7010358123  
Fax    
Email  muthukumaransmv@gmail.com  
 
Source of Monetary or Material Support  
Sri Manakula Vinayagar Medical college and Hospital, Madagadipet, kalitheerthalkuppam,puducherry-605107 
 
Primary Sponsor  
Name  Muthukumaran 
Address  No.79, 2nd main road, kauvery nagar, reddiarpalayam, Puducherry -605010 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMuthukumaran  Sri Manakula Vinayagar Medical College and Hospital  Department of anaesthesia, First floor Operation theater complex, demo room no.1 ,Madagadipet, Kalitheerthalkuppam, Puducherry 605107.
Pondicherry
PONDICHERRY 		 7010358123

muthukumaransmv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH-ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18-60 years
patient of either sex
patient posted for elective surgeries who are fit under ASA PS I and II 
 
ExclusionCriteria 
Details  1)Patients with heart failure
2)Autonomic nervous system disorder
3)Portal hypertension
4) Respiratory distress
5)Valvular heart disease
6) Emergency surgeries
7) Anticipated difficult airway
8)Major peripheral vascular disease
9)Systolic blood pressure >180mmHg and <90mmHg.
10)Diastolic blood pressure >100mmHg and <60mmHg
and pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is to assess the ability of subclavian vein collapsibility index & inferior vena cava collapsibility index in predicting hypotension in spinal anaesthesia.  Time points will be 1 to 3 hours according to the duration of surgeries the primary outcome of the study is to assess the ability of subclavian vein collapsibility index & inferior vena cava collapsibility index in predicting hypotension in spinal anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 

The secondary outcome is to validate subclavian vein collapsibility index as an alternative to inferior vena cava collapsibility index (CI) in predicting intravascular volume status.
 		 time points will be 1 to 3 hours according to the duration of surgery 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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)   12/09/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Title: PREOPERATIVE  EVALUATION OF COLLAPSIBILITY INDEX - SUBCLAVIAN VEIN AND INFERIOR VENA CAVA FOR PREDICTING HYPOTENSION IN SPINAL ANAESTHESIA

Purpose: The purpose of the study is to assess the ability of subclavian vein collapsibility index and inferior vena cava collapsibility index in predicting hypotension in spinal anaesthesia.

Study design: prospective observational study.

Sample size:136.

 Objectives: To assess the ability of ultrasonographic measurement of Subclavian vein and inferior vena cava diameter, collapsibility index (CI) to predict hypotension after induction of spinal anaesthesia and secondary is to validate subclavian vein collapsibility index as an alternative to inferior vena cava collapsibility index (CI) in predicting intravascular volume status.

 
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