| 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
|
|
|
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
|
|
|
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. |