| CTRI Number |
CTRI/2025/04/083773 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
This study helps to understand how measurement of the diameter of certain blood vessels in the body can help in predicting a fall in blood pressure that could happen after spinal anesthesia in patients undergoing surgeries under spinal anesthesia |
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Scientific Title of Study
|
Efficacy of Inferior Vena Cava Collapsibility Index, Internal Jugular Vein Collapsibility Index and Caval Aorta Index in predicting the incidence of hypotension after spinal anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aleena Treasa Rodrigues |
| Designation |
PG Resident |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anaesthesiology,
St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka
Bangalore KARNATAKA 560034 India |
| Phone |
7022158740 |
| Fax |
|
| Email |
aleenarodrigues21@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sathyanarayana P S |
| Designation |
Professor, Deptartment of Anaesthesiology |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anaesthesiology,
St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka
Bangalore KARNATAKA 560034 India |
| Phone |
9448066128 |
| Fax |
|
| Email |
sathyanarayananair@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sathyanarayana P S |
| Designation |
Professor, Deptartment of Anaesthesiology |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anaesthesiology,
St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka
Bangalore KARNATAKA 560034 India |
| Phone |
9448066128 |
| Fax |
|
| Email |
sathyanarayananair@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College and Hospital
Bangalore
KARNATAKA
560034
India |
|
|
Primary Sponsor
|
| Name |
Dr Aleena Treasa Rodrigues |
| Address |
Department of Anaesthesiology,
St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Dr Aleena Treasa Rodrigues |
St Johns Medical College Hospital |
Department of Anaesthesiology, 1,2 and 3 floor operation theatre, St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka Bangalore KARNATAKA |
7022158740
aleenarodrigues21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St Johns Medical College Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender of the age group eighteen to fifty nine years
2. Consenting to the study
3. Belonging to American Society of Anaesthesiologists physical status one or two
4. Undergoing elective surgery under spinal anaesthesia.
5. The patient has to be in supine position for the entire duration of surgery.
|
|
| ExclusionCriteria |
| Details |
1. Patients with hypertension
2. Patients with LVEF less than forty percent
3. Patients with increased intraabdominal pressure
4. Patients with BMI greater than thirty kilogram per meter square
5. Surgeries done under unilateral spinal anaesthesia
6. Pregnant patients
7. Failure to perform spinal anaesthesia.
8. After recruitment, if level of anaesthesia achieved is above thoracic level five
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the sensitivity of IVC collapsibility index, IJV collapsibility index and aorta caval index in predicting spinal anaesthesia induced hypotension in adults undergoing surgery in supine position |
Baseline vitals are noted along with measurement of IVC, IJV and aorta diameter. NIBP, HR and SpO2 will be recorded every 2 minutes for the first 10 minutes and every 5 minutes until 30 mins after spinal anaesthesia. Outcome would be presence of hypotension post spinal anaesthesia, and that will be measured intraoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To associate other baseline patient specific parameters with spinal anaesthesia induced hypotension |
Baseline vitals are noted along with measurement of IVC, IJV & aorta diameter. NIBP, HR & SpO2 will be recorded every 2 minutes for the first 10 minutes & every 5 minutes until 30 mins after spinal anaesthesia. Outcome would be presence of hypotension post spinal anaesthesia, & that will be measured intraoperatively. |
|
|
Target Sample Size
|
Total Sample Size="85" Sample Size from India="85"
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)
|
08/04/2025 |
| 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="2" Months="0" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aleenarodrigues21@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
After obtaining approval from
Institutional Ethics Committee and written informed consent from the
participants, patients will be recruited in accordance with the predefined
inclusion and exclusion criteria. These pre – operative parameters will
be recorded
1. Age
2. Gender
3. Weight
4. Height
5. BMI
6. ASA grade
7. Baseline BP and MAP
8. Baseline HR
9. Baseline oxygen saturation
All patients will be fasting as per standard protocol (6 hrs
for solids and 2 hrs for clear liquids). On the day of surgery, USG measurement
of IVC, IJV and aorta diameters will be done in the preoperative holding area
by a trained operator, with the patients in supine position. A phased array
probe of a standard USG machine will be used for the study.
Inferior Venacava Measurement:
With the transducer kept in the subxiphoid region, IVC measurements
will be taken lateral to the IVC - hepatic vein junction. In one respiratory
cycle IVC AP diameter during expiration (IVCmax) and inspiration
(IVCmin) will be measured.

Aorta Measurement:
The transducer will be kept in the subxiphoid region. Aorta will
be identified and maximum aorta internal diameter at systole will be measured.

Internal Jugular Vein Measurement:
The transducer will be kept lateral to the middle level of
thyroid cartilage and a clear transverse view of the IJV will be obtained. In
one respiratory cycle, IJV diameter during expiration (IJVmax) and
inspiration (IJVmin) will be measured.

Procedure for spinal anaesthesia:
Intraoperatively, non-invasive blood pressure (NIBP) to
measure the systolic, diastolic blood pressures and mean arterial pressure,
heart rate, 5 lead ECG and oxygen saturation will be monitored. Availability of
IV access with appropriate gauge IV canula in a peripheral line will be
ensured. After the administration of spinal anaesthesia, intraoperative
infusion of crystalloid solution at the rate of 10ml/kg/hr will be started.
Sub arachnoid block (SAB) will be administered to the
patient positioned as sitting, with 25G Quincke – Babcock needle, at the L3-L4
or L4-L5 intervertebral space, and 3ml, 0.5% Hyperbaric Bupivacaine will be
instilled in the space. Patient will be kept supine after SAB throughout the
study period (30 mins). After recruitment, if level of anaesthesia achieved is
above T5, then that patient will be excluded from the analysis.
NIBP, HR and SpO2 will be recorded every 2 minutes for the
first 10 minutes and every 5 minutes until 30 mins after SAB. Post spinal
anaesthesia hypotension is defined as fall in SBP by more than 20% of baseline
OR absolute value of SBP < 90 mm Hg OR MAP less than 60 mm Hg. Any episode
of hypotension will be noted and managed with 6 mg IV Mephentermine or
Ephedrine to keep BP within 20% of baseline. Complications like bradycardia,
nausea or vomiting will also be noted and managed accordingly. |