FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092345 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Ultrasound based comparison of efficacy in prediction of Low Blood Pressure After general anaesthesia using various preoperative vein and artery measurements  
Scientific Title of Study   A comparative study on efficacy of preoperative evaluation of inferior venacaval collapsibility index,caval aorta index,ratio of diameter of femoral vein to femoral artery in predicting post induction hypotension 
Trial Acronym  IVC-INFERIOR VENACAVA IVC-CI-inferior venacaval collapsibility index C/A index-caval aorta index FV/FA ratio-femoral vein to femoral artery ratio 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sreelakshmi V 
Designation  Junior resident 
Affiliation  Amala institute of medical sciences  
Address  Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur
Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur
Thrissur
KERALA
673614
India 
Phone  9497049652  
Fax    
Email  sreelakshmikhoranas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Derlin Thomas 
Designation  Associate professor 
Affiliation  Amala institute of medical sciences  
Address  Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur
Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur,680555
Thrissur
KERALA
680555
India 
Phone  8714340188  
Fax    
Email  derlin.t@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajagopal P 
Designation  Associate professor  
Affiliation  Amala institute of medical sciences  
Address  Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur
Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur,680555
Thrissur
KERALA
680555
India 
Phone  9995555239  
Fax    
Email  rajagopaltall@yahoo.co.in  
 
Source of Monetary or Material Support  
Amala institute of medical sciences,Amalanagar, Thrissur,680555 
 
Primary Sponsor  
Name  Amala institute of medical sciences  
Address  Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur,680555 
Type of Sponsor  Private medical college 
 
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 
Dr Derlin Thomas  Amala institute of medical sciences   Amala institute of medical sciences,Department of anesthesiology,Amalanagar, Thrissur,680555
Thrissur
KERALA 		 9447768944

derlin.t@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AMALA INSTITUTE OF MEDICAL SCIENCES  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 
Comparator Agent  Nil  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Cases posted for elective surgeries under general anaesthesia
ASA 1&2 
 
ExclusionCriteria 
Details  pregnant females
patients with lower extremity artery/vein thrombosis
patients with significant lower extremity artery plaque
patients with lower extremity artery occlusion
patients with inferior venacaval filter implantation
patients with lower extremity varicose veins
neuroendocrine disorders,pheochromocytoma 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Inferior Vena caval Collapsibility Index,Caval Aorta Index,Ratio Of Diameter Of Femoral Vein to Femoral Artery Predicts Post Induction Hypotension  3 minutes,6 minutes,9 minutes,12 minutes,15 minutes,20 minutes,25 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Ratio Of Diameter Of Femoral Vein to Femoral Artery Predicts Post Induction Hypotension  3 minutes,6 minutes,9 minutes,12 minutes,15 minutes,20 minutes,25 minutes 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   18/08/2025 
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="3"
Months="0"
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 - 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-11-2024 and end date provided 31-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   After getting approval from institutional research and ethical commitee all consenting patients posted for elective surgery under general anathesia and fulfilling inclusion & exclusion criteria.Documents which information about proposed study will be provided to patients.consent will be obtained.In pre anaesthesia room both IVC:A0 INDEX,IVC COLLAPSIBILITY INDEX,FEMORAL AETERY AND FEMORAL VEIN DIAMETER RATIO will be measured using USG ,Then we will measure intraoperative  bp at every 3 minutes for 15 minutes then thereafter 5 mintes for next 15 minutes.from patients having hypotension we will compare the accuracy of our 3 parameters in predicting post induction hypotension. 
Close