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CTRI Number  CTRI/2020/12/029511 [Registered on: 02/12/2020] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Diagnostic study 
Study Design  Other 
Public Title of Study   A study to observe accuracy of variation in the diameter with breathing of two large vein for predicting decrease in blood pressure after anaesthesia. 
Scientific Title of Study   Diagnostic accuracy of subclavian vein collapsibility index versus inferior vena cava collapsibility index for predicting post induction hypotension: An observational study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadik Mohammed 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Near Mohammedi Masjid, Hanuman Ji Ki Bhakhari, Nai Sarak, Jodhpur. Rajasthan.
Department of Anaesthesiology and Critical Care, 3rd Floor, OPD Block, All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342001
India 
Phone  9414849733  
Fax  0291-2740741  
Email  drmsadik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sadik Mohammed 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Near Mohammedi Masjid, Hanuman Ji Ki Bhakhari, Nai Sarak, Jodhpur. Rajasthan.
Department of Anaesthesiology and Critical Care, 3rd Floor, OPD Block, All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342001
India 
Phone  9414849733  
Fax  0291-2740741  
Email  drmsadik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gaurav Chaudhary 
Designation  PG Student 
Affiliation  AIIMS, Jodhpur 
Address  Department of Anaesthesiology and and Critical Care, 3rd Floor, OPD Block, All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9711371496  
Fax    
Email  garvjipmer@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Basani Phase II, Jodhpur, Rajasthan 342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Basani Phase II, Jodhpur, Rajasthan 342005 
Type of Sponsor  Research institution and hospital 
 
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 
Gaurav Chaudhary  All India Institute of Medical Sciences  Department of Anaethesiology and Critical Care, 3rd Floor, OPD Block, AIIMS Hospital, Basani Phase II
Jodhpur
RAJASTHAN 		 9711371496
0291-2740741
garvjipmer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, Jodhpur, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients of either sex of age 18 to 85 years and scheduled for elective surgery under general anesthesia. 
 
ExclusionCriteria 
Details  Autonomic nervous system disorders
Implanted pacemaker/ cardioverter
Mental incompetence/ non cooperation
Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare diagnostic accuracies of SCV-CI and IVC-CI for prediction of post induction hypotension during quiet breathing.  From Induction of Anaesthesia till 20 minutes after induction 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the diagnostic accuracies of SCV-CI and IVC-CI for prediction of post induction hypotension during deep breathing.
2. Time needed to acquire ultrasound images and measure venous diameter,
3. To measure incidence of hypotension after induction.
4. To measure intraoperative fluid requirement.
 		 From Induction of Anaesthesia till 20 minutes after induction 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/12/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/01/2022 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Chaudhary G, Mohammed S, Biyani G, Chhabra S, Bhatia PK, Kamal M, Kumar R, Kumari K. Diagnostic accuracy of subclavian vein versus inferior vena cava collapsibility index for predicting postinduction hypotension: An observational study. Saudi J Anaesth. 2024 Oct-Dec;18(4):496-503. 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drmsadik@gmail.com].

  6. For how long will this data be available start date provided 19-11-2022 and end date provided 19-01-2027?
    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   Ultrasound (US) guided measurement of inferior vena cava (IVC) diameter and it’s respiratory variability i.e collapsibility index (CI) has been shown to predict the post induction hypotension with high sensitivity and specificity. However, in conditions like pregnancy, abdominal distension, obesity etc it is difficult to scan the IVC and to assess the volume status. The role of US guided measurements of other central veins like internal jugular vein, femoral vein etc in predicting the volume status were also evaluated. The diagnostic accuracy for them was found to be inferior to the IVC. Recently, the sub clavian vein (SCV) CI  during deep inspiration was shown to predict the post induction hypotension. In the available literature there is no head to head comparison of IVC and SCV for prediction of post induction hypotension. Therefore in our study we will compare the diagnostic accuracy of US guided measurement of IVC and SCV parameters during quiet and deep breathing for predicting post induction hypotension. We hypothesize that there will be no difference between the diagnostic accuracy of SCV- CI and IVC-CI for prediction of post induction hypotension. 
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