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CTRI Number  CTRI/2023/06/054140 [Registered on: 20/06/2023] Trial Registered Prospectively
Last Modified On: 19/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Single Arm Study 
Public Title of Study   A comparative study of The Caval-aorta index with The Ratio of diameters of Femoral vein to Femoral Artery to determine the better predictor of general anesthesia induced hypotension. 
Scientific Title of Study   Comparison of pre-operative ultrasonographic evaluation of Caval-Aorta index with the ratio of Femoral vein diameter to Femoral artery diameter for predicting hypotension during induction of general anesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUBHAJEET MAHAPATRA 
Designation  JUNIOR RESIDENT 
Affiliation  ABVIMS AND DR. RML HOSPITAL 
Address  F-254, F BLOCK, NEW RAJENDER NAGAR, NEW DELHI - 110060
DEPARTMENT OF ANESTHESIA PGI BUILDING 3RD FLOOR ABVIMS AND DR. RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE, NEW DELHI
Central
DELHI
110060
India 
Phone  9438718188  
Fax    
Email  DrSubhajeetmahapatra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. SANJEEV SHARMA 
Designation  PROFESSOR 
Affiliation  ABVIMS AND DR. RML HOSPITAL 
Address  DEPARTMENT OF ANESTHESIA PGI BUILDING 3RD FLOOR ABVIMS AND DR. RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE, NEW DELHI

Central
DELHI
110060
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Details of Contact Person
Public Query  
Name  SUBHAJEET MAHAPATRA 
Designation  JUNIOR RESIDENT 
Affiliation  ABVIMS AND DR. RML HOSPITAL 
Address  DEPARTMENT OF ANESTHESIA PGI BUILDING 3RD FLOOR ABVIMS AND DR. RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE, NEW DELHI

Central
DELHI
110060
India 
Phone  9438718188  
Fax    
Email  DrSubhajeetmahapatra@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia, ABVIMS AND DR. RML HOSPITAL 
 
Primary Sponsor  
Name  Department of Anesthesia 
Address  ABVIMS AND DR. RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE, NEW DELHI - 110001 
Type of Sponsor  Government 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 
SUBHAJEET MAHAPATRA  DR. RML HOSPITAL  DEPARTMENT OF ANESTHESIA PGI BUILDING 3RD FLOOR ABVIMS AND DR. RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE, NEW DELHI- 110001
Central
DELHI 		 9438718188

DrSubhajeetmahapatra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, ABVIMS, Dr. RML Hospital, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I952||Hypotension due to drugs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CAVAL-AORTA INDEX  The ratio of diameters of Inferior Vena Cava and Abdominal Aorta measured in the pre-operative period. 
Comparator Agent  Ratio of Femoral vein diameter to Femoral Artery Diameter  Ratio of Diameters of Femoral vein and Femoral artery meqaaured in the pre-operative area 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Individuals of 18 years or more, of both sexes 
 
ExclusionCriteria 
Details  1. Patient with Cardiovascular diseases (Heart failure, Valvular heart diseases, MI, Aortic
diseases, Peripheral vascular diseases)
2. Portal hypertension
3. Pregnant Female
4. Patient with lower limb injuries
5. Patient with hernia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Diameter of Inferior Vena Cava
Diameter of Abdominal Aorta
Diameter of Femoral Vein
Diameter of Femoral Artery
Heart rate
Systolic blood Pressure.
Diastolic blood pressure.
Mean arterial pressure 		 Diameter of Inferior Vena Cava, Diameter of Abdominal Aorta, Diameter of Femoral Vein, Diameter of Femoral Artery - preoperatively before induction of anesthesia

Heart rate, Systolic blood Pressure, Diastolic blood pressure, Mean arterial pressure - at 0minute, 1st min, 2nd min, 3rd min, 4th min, 5th min after induction of anesthesia
 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of fasting
Body Mass Index 		 Duration of fasting 6hours
BMI & effect of drugs on BP 
 
Target Sample Size   Total Sample Size="97"
Sample Size from India="97" 
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)   30/06/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  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 - Any purpose.

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

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-06-2027?
    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   This study is a cross-sectional observational study comparing pre-operative ultrasonographic assessment of caval-aorta index with the ratio of diameters of femoral vein to femoral artery for predicting hypotension during induction of general anesthesia. The study will be conducted in the department of anesthesia, ABVIMS &DR, RML Hospital, New delhi. The primary outcomes will be the Diameter of IVC, Aorta, Femoral vein, Femoral Artery, & Blood pressure, Mean Arterial Pressure, Heart Rate. 
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