| CTRI Number |
CTRI/2024/10/074955 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of inferior vena cava collapsibility index in prediction of post-spinal hypotension: An observational prospective study. |
|
Scientific Title of Study
|
Assessment of inferior vena cava collapsibility index in prediction of post-spinal hypotension: An observational prospective 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 N Akhil Maaran |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Anaesthesiology 1st floor A Block Aarupadai Veedu Medical College and Hospital Kirumambakkam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8667623239 |
| Fax |
|
| Email |
akhil.ida@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Rajesh Prabhu |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Anaesthesiology 1st floor A Block Aarupadai Veedu Medical College and Hospital Kirumambakkam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843360106 |
| Fax |
|
| Email |
cr.prabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Sivaperumal |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Anaesthesiology 1st floor A Block Aarupadai Veedu Medical College and Hospital Kirumambakkam Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9080107086 |
| Fax |
|
| Email |
perumalgod@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Anaesthesiology 1st floor A Block Aarupadai Veedu Medical College and Hospital Kirumambakkam Puducherry |
| Type of Sponsor |
Private 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 |
| Dr N Akhil Maaran |
Department of Anaesthesiology 1st floor A Block Aarupadai Veedu Medical College and Hospital |
Department of Anaesthesiology 1st floor A Block Aarupadai Veedu Medical College and Hospital Kirumambakkam Pondicherry
Pondicherry
PONDICHERRY |
8667623239
akhil.ida@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms, (2) ICD-10 Condition: K412||Bilateral femoral hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (4) ICD-10 Condition: M254||Effusion of joint, (5) ICD-10 Condition: N433||Hydrocele, unspecified, (6) ICD-10 Condition: K36||Other appendicitis, (7) ICD-10 Condition: N358||Other urethral stricture, (8) ICD-10 Condition: N350||Post-traumatic urethral stricture, (9) ICD-10 Condition: N440||Torsion of testis, (10) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inferior vena cava collapsablity index using Ultrasound |
Inferior vena cava collapsablity index using Ultrasound |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II
Patients scheduled for sub umbilical surgeries
Patients planned for spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients of ASA III & above
Patients undergoing cardiovascular & obstetric surgery
Known Hypotensive/Hypertensive patients
Contraindication for spinal anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To monitor inferior vena cava collapsibility index (IVCCI) preoperatively and assess if it can predict the incidence of post spinal hypotension |
20 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
10/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| 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 Applicable |
| 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 is one of the most common side effects of spinal
anaesthesia Hypotension occurs due to sympathetic blockade and decreased
systemic vascular resistance resulting in reduced venous return and
decreased cardiac output PSH may be associated with nausea vomiting syncope dizziness cardiac
arrhythmias cardiac arrest and may sometimes lead to death Therefore predicting PSH is particularly important so that preventive measures or timely
interventions can be taken to avoid untoward events Ultrasonographic
assessment of the inferior vena cava collapsibility index is easy to
perform non-invasive time-efficient and readily available as well Preoperative
IVCCI is a reliable predictor of hypotension after induction of general
anaesthesia with high specificity We hypothesized that
patients with increased respiratory variations in IVC diameter would have more
chances of developing PSH |