| CTRI Number |
CTRI/2024/06/068381 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised control trial to assess the predictive accuracy of preoperative ultrasonographic collapsibility index of Subclavian Vein vs. Inferior Vena Cava for hypotension in Cesarean Section under Spinal Anesthesia |
|
Scientific Title of Study
|
A randomised control trial to assess the predictive accuracy of preoperative ultrasonographic collapsibility index of Subclavian Vein vs. Inferior Vena Cava for hypotension in Cesarean Section under Spinal Anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMohanapriya |
| Designation |
Post Graduate |
| Affiliation |
Indira Gandhi medical College and research institute, Puducherry |
| Address |
Department of Anesthesiology OT complex, Hospital Block
Indira Gandhi medical College and research institute
Kadhirkamam,Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9688294296 |
| Fax |
|
| Email |
priyaa10081994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Dhanger |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi medical College and research institute, Puducherry |
| Address |
Department of Anesthesiology OT complex, Hospital Block Indira Gandhi medical College and research institute
Kadhirkamam
Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
8489165915 |
| Fax |
|
| Email |
drsangeet2023@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMohanapriya |
| Designation |
Post Graduate |
| Affiliation |
Indira Gandhi medical College and research institute, Puducherry |
| Address |
Department of Anesthesiology OT complex, Hospital Block Indira Gandhi medical College and research institute
Kadhirkamam
Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9688294296 |
| Fax |
|
| Email |
priyaa10081994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi medical College and research institute
Kadhirkamam
Puducherry 605009
India |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Indira Gandhi medical College and research institute
Kadhirkamam
Puducherry 605009 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrMohanapriya |
Indira Gandhi Medical College and Research Institute Puducherry |
Department of Anesthesiology
OT Complex, Hospital Block
Indira Gandhi medical College and research institute
Kadhirkamam
Puducherry
Pondicherry
PONDICHERRY |
9688294296
priyaa10081994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Blood pressure assessment |
Minimum mandatory monitoring like heart rate, saturation, blood pressure, respiratory rate are recorded before giving spinal anaesthesia. after giving spinal anaesthesia blood pressure is monitored and recorded every 5 mins. Fall in blood pressure 20% from the baseline blood pressure is considered hypotension and treated with IV fluids and drugs.
The patient is monitored and blood pressure is recorded for the duration of surgery |
| Intervention |
Ultrasonographic evaluation of Collapsibility index of subclavian vein vs inferior vena cava |
The subclavian vein is identified by using b mode of ultrasound machine by scanning below the clavicle and the maximum and minimum measurement of the vessel is measured using m mode of ultrasound machine. Using the formula( maximum diameter -minimum diameter/ maximum diameter)×100 Collapsibility index is calculated. Similarly inferior vena cava is identified using b mode of ultrasound machine in right upper quadrant of abdomen and maximum and minimum diameter is measured using m mode. Collapsibility index is calculated using above mentioned formula. This procedure will take less than 10 mins to perform.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Parturients more than 36 weeks
Scheduled for elective cesarean section under ASA 2
No known pre-existing conditions that significantly impact cardiovascular function |
|
| ExclusionCriteria |
| Details |
Parturients refusal
Parturients with contraindications to spinal anaesthesia
History of known vascular or pathological abnormalities affecting subclavian vein or inferior vena cava
Parturients with multiple gestations
Emergency cesarean sections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hypotension after spinal anesthesia |
Every 5 minutes intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hypotension in intra operative period |
Every 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/06/2024 |
| 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
|
The aim of this study is to compare the predictive accuracy of preoperative ultrasonographic evaluation of Collapsibility index of subclavian vein vs inferior vena cava in post spinal hypotension in cesarean section operations The rationale behind this study lies in the potential of preoperative ultrasound evaluations of the subclavian vein and inferior vena cava to provide early insights into vascular dynamics, offering a non invasive means to anticipate and manage spinal anesthesia induced hypotension |