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CTRI Number  CTRI/2025/10/096135 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound Based Comparison Of Caval Aorta Index And Subclavian Vein Collapsibility Index For Predicting Hypotension During Induction Of General Anesthesia In Adult Patient  
Scientific Title of Study   Comparison Of Pre-Operative Ultrasonographic Evaluation Of Caval-Aorta Index With Subclavian Vein Collapsibility Index For Prediction Of Hypotension During Induction Of General Anesthesia In Adult Patient 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jasmin 
Designation  Post Graduate Student  
Affiliation  ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi 
Address  Room no.301, 3rd floor, Department Of Anaesthesia, ABVIMS and Dr RML Hospital, Central Delhi, Delhi, India

Central
DELHI
110001
India 
Phone  9650886048  
Fax    
Email  panda.jasmin1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sanjeev Sharma 
Designation  Professor 
Affiliation  ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi 
Address  Room no.301, 3rd floor, Department Of Anaesthesia, ABVIMS and Dr RML Hospital, Central Delhi, Delhi, India

Central
DELHI
110001
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sanjeev Sharma 
Designation  Professor 
Affiliation  ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi 
Address  Room no.301, 3rd floor, Department Of Anaesthesia, ABVIMS and Dr RML Hospital, Central Delhi, Delhi, India

Central
DELHI
110001
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharark Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001 Central Delhi  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Jasmin Panda  ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi  Room no.301 3rd floor Department Of Anaesthesia A.B.V.I.M.S AND DR. RML HOSPITAL Central DELHI 110001 India North DELHI
Central
DELHI 
9650886048

panda.jasmin1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ABVIMS and 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: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients (more than 18 years)
2. American Society of Anesthesiology Physical Status 1 & 2
 
 
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.Patients with neck surgeries
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic parameters
1. Heart rate
2. Systolic blood Pressure.
3. Diastolic blood pressure.
4. Mean arterial blood pressure
 
at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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)   26/10/2025 
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="1"
Months="3"
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 - NO
Brief Summary  

Pre-Operative Measurement of Indices

 The patient will be wheeled into the pre operative area, and the procedures will be explained  to the patient and informed written consent will be obtained in a language that is understood  by the patient. Following this, the diameters of the Inferior Vena Cava, Abdominal Aorta,  Subclavian vein will be measured in supine position, as described below

 

 To  measure Caval Aorta index

 The IVC diameter will be measured using a curvilinear probe of 2 to 5MHz of the USG  machine. The probe will be placed in the subxiphoid region where the confluence of the  hepatic veins can be visualized that drain into the IVC in the B mode. 1cm caudal to the confluence of the  hepatic veins and IVC, the greatest internal anterior posterior diameter of the IVC in the  longitudinal plane will be measured, in the M mode. In the subxiphoid region, lying left  lateral to the IVC, will be the Aorta; the maximum internal AP diameter of the Abdominal  Aorta will be measured in the longitudinal plane, on the M mode 10 mm above the coeliac trunk.

 

 

                       Ultrasound guided Subclavian Vein Measurements

Ultrasonographic measurements will be performed before induction of general anesthesia . All patients will lie at supine position  and breathing spontaneously for at least 5 min before assessment. Right SCV diameters will be measured in the supine position using ultrasonography device and a high-frequency linear probe 6 to 14MHz. The short axis image of the SCV will be obtained by placing the probe just below the clavicle and scanning it from the midline laterally.

The patient in the supine position will be asked to do a normal inspiration and then a deep inspiration which is as deeply as possible and exhale naturally, and the minimum diameter and maximum diameter of the SCV will be measured in the M mode of ultrasound at a medium sweep speed during both normal and deep inspiration.

                       The mean of three measurements will be selected. 

 

                        Anesthetic Procedure

In the operation theatre, ASA standard monitors will be attached to the patient. The values of  Heart rate , systolic blood pressure , diastolic blood pressure  and mean  blood pressure, obtained in supine position before any intervention or drug  administration will be considered as Baseline Values. A 18G peripheral intravenous cannula  will be secured, and Ringer Lactate infusion will be started 10ml per kg per hr. Following drugs  will be administered for induction of general anesthesia.  Premedication with Inj. Midazolam  1mg i.v. stat, Inj. Fentanyl 2mcg per kg for analgesia Induction with Inj. Propofol 2mg per kg  for induction inhalational agent used will be Sevoflurane 2 to 4 percent to achieve a MAC of 1.0, &  Inj. Vecuronium 0.1mg per kg for muscle relaxation. For the next five minutes, the  hemodynamic parameters, i.e., HR, SBP, DBP, & MAP, will be measured every minute.  During these five minutes, the patient will be ventilated by volume-controlled mode with the  following ventilation setting: Tidal volume 6 to 8ml per kg, Frequency 12 per min, PEEP 0 cm of

 H  2 O, Inspiratory and expiratory ratio of 1 and 2. After the fifth minute, the        patient will be intubated to secure the airway.  Hypotension will be defined as a fall of SBP by more than 20 percent at any point of time, and it will be  treated by giving IV fluid, and or Inj. Mephentermine 3 to 6 mg i.v. bolus.                   

 
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