CTRI

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CTRI Number

CTRI/2025/04/085644 [Registered on: 25/04/2025] Trial Registered Prospectively

Last Modified On:

24/04/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Using an ultrasound test to predict if blood pressure might drop after giving an injection in the back to block pain during caesarean section

Scientific Title of Study

To study the role of inferior venecava collapsibility index measured in left lateral position to predict post spinal anaesthesia hypotension in women undergoing elective caesarean section a prospective observational cross sectional study

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 Salva P
Designation	Post Graduate Junior Resident Anaesthesiology
Affiliation	AIIMS RAIPUR
Address	Department of Anaesthesiology AIIMS Raipur Raipur Chattisgarh Raipur CHHATTISGARH 492099 India
Phone	8301000332
Fax
Email	Salvapalliyalil@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sarita Ramchandani
Designation	Additional Professor
Affiliation	AIIMS RAIPUR
Address	Department of Anesthesiology AIIMS Raipur Raipur Chattisgarh Raipur CHHATTISGARH 492099 India
Phone	9424204244
Fax
Email	drsaritaramchandani@gmail.com

Details of Contact Person
Public Query

Name	Dr Sarita Ramchandani
Designation	Additional Professor
Affiliation	AIIMS Raipur
Address	Department of Anaesthesiology AIIMS Raipur Raipur Chattisgarh Raipur CHHATTISGARH 492099 India
Phone	9424204244
Fax
Email	drsaritaramchandani@gmail.com

Source of Monetary or Material Support

All India Institute of Medical Sciences Raipur Chattisgarh 492099 India

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
Dr Salva P	AIIMS RAIPUR	Department of Anaesthesiology Obstetrics and Gynaecology OT 1st floor A block Raipur Chattisgarh Raipur CHHATTISGARH	8301000332 Salvapalliyalil@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee AIIMS Raipur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O746\|\|Other complications of spinal andepidural anesthesia during labor and delivery,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	Pregnant women aged 18 to 40 years Gestational age more than or equal to 37 weeks Singleton pregnancy American Society of Anaesthesiologists Physical Status I and II Undergoing elective caesarean section under spinal anaesthesia

ExclusionCriteria

Details

Refusal by patient
Uncontrolled systemic comorbidities like diabetes hypertension
Cardiovascular respiratory or renal impairment
Patient in whom massive intraoperative blood loss is expected
Hemoglobin less than 7 gram per decilitre
Parturients who receive preloading of intravenous fluid

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To study the role of inferior venecava collapsibility index in left lateral position to predict post spinal anaesthesia hypotension in women undergoing caesarean section	Baseline, immediately after spinal anaesthesia ,3 minutes, 6 minutes, 9 minutes, 12 minutes, 15 minutes after spinal anaesthesia

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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)

26/05/2025

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="6"
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

Post spinal anaesthesia hypotension,PSAH, is a common clinical problem, occuring in upto 70 percentage of cases of caesarean section. PSAH can lead to severe maternal and fetal outcomes. Preanaesthetic identification of the fluid deficit may help prevent the critical decrease in blood pressure during operation. The inferior vena cava collapsibility index, IVCCI, has been used as a quantitative measure to assess the extent of IVC collapse and thus guide fluid therapy with an acceptable diagnostic reliability. Till date most of the studies for predicting PSAH by assessing the preoperative IVCCI through ultrasound guidance have been done in non obstetric population with very few such studies in obstetric population that too with patient in supine position. So we propose to conduct the study to know the role of IVCCI through ultrasound guidance in left lateral position to predict PSAH in pregnant women undergoing elective caesarean section. We hypothesis that IVCCI measured in left lateral position can predict PSAH in women undergoing elective caesarean section. The study will be started after obtaining approval from the Institute Ethics Committee and written and informed consent from the participants. On receiving patient at the Preoperative area pre anaesthetic records of the patients will be reviewed and height, weight, BMI of patient will be noted. Inferior Vena cava diameters will be measured using echocardiographic probe, 1to 5 MHz by M mode in sub xiphoid approach. IVCCI will be calculated by the following formula IVCCI is IVCd max minus IVCd min divided by IVCdmax multiplied by 100 where, IVCCI is the inferior venacava collapsibility index IVCd max is the maximum IVC diameter at end of expiration IVCd min is the minimum IVC diameter at end of inspiration. On receiving the patients in operating room, ASA standard monitors will be applied and baseline vital parameters will be recorded. Subarachnoid block will be administered with 2ml of hyperbaric bupivacaine 0.5 percentage. Thereafter heart rate ,systolic blood pressure, diastolic blood pressure and mean arterial pressure of patient will be recorded throughout the procedure at every 3 minutes interval for first 15 min of administration of spinal anaesthesia. Hypotension, defined as reduction in mean arterial pressure more than 20 percentage from the baseline and or MAP less than 65 mm Hg and bradycardia ,defined as heart rate less than 50 beats per minute will be recorded and treated according to standard institutional protocol.