| CTRI Number |
CTRI/2023/01/049240 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Measurement of Inferior Vena Cava Size to Predict Hypotension and Guide Intra-operative Fluid Management |
|
Scientific Title of Study
|
Prediction of Hypotension using Inferior Vena Cava Collapsibility Index to Guide Fluid Management After Spinal Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagasobbanaa Manukaran |
| Designation |
Junior resident of Anaesthesiology |
| Affiliation |
Sri Devaraj URS Academy of Higher Education & Research |
| Address |
Department of Anaesthesiology, Sri Devaraj URS Academy of Higher Education & Research,
Kolar
KARNATAKA
563101
India |
| Phone |
9791859349 |
| Fax |
|
| Email |
anaesthesiologypgstuff@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi M |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
Sri Devaraj URS Academy of Higher Education & Research |
| Address |
Department of Anesthesiology,Sri Devaraj URS Medical College, Sri Devaraj URS Academy of Higher Education & Research
Kolar
KARNATAKA
563101
India |
| Phone |
9845287591 |
| Fax |
|
| Email |
ravijaggu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi M |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
Sri Devaraj URS Academy of Higher Education & Research |
| Address |
Department of Anesthesiology,Sri Devaraj URS Medical College, Sri Devaraj URS Academy of Higher Education & Research
Kolar
KARNATAKA
563101
India |
| Phone |
9845287591 |
| Fax |
|
| Email |
ravijaggu@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education,
563101 Kolar, Karnataka |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education |
| Address |
TAMAKA, KOLAR – 563101, KARNATAKA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nagasobbanaa Manukaran |
R.L.JALAPPA HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF ANAESTHESIOLOGY, SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH
TAMAKA, KOLAR – 563101
Kolar
KARNATAKA |
9791859349
anaesthesiologypgstuff@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Devaraj Urs Academy of Higher Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inferior Vena cava collapsibility index (IVCCI) |
maximum (dIVCmax) and the minimum (dIVCmin) anteroposterior diameters of the inferior vena cava (IVC) at the end of expiration and inspiration are taken during the same respiratory cycle throughout the surgery. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status grades I– II
Patients scheduled for non-cardiovascular, non-obstetric surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Pre-existing hypotension (defined as systolic arterial pressure <90 mmHg or mean arterial pressure <60mm Hg)
Severe cardiovascular disease [unstable angina or ejection fraction <40%, implanted pacemaker/cardioverter
Decompensated heart failure
Elevated pulmonary arterial pressure >40 mmHg
Contraindication for spinal anaesthesia, canal stenosis, pregnant patients, body mass index (BMI) >30 kg/m2,
Failure to perform spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the degree of relationship between preoperative IVCCI and incidence of hypotension during surgery done under spinal anaesthesia. |
1st minute,2nd minute, 3rd minute, 4th minute,5th minute,10th minute,15th minute, 20th minute, 25th minute, 30th minute, 60th minute, 90th minute, 120th minute, 150th minute, 180th minute, 210th minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the ideal volume of crystalloid to be administered intraoperatively for optimum fluid correction based on preoperative IVCCI to prevent post-spinal hypotension. |
After spinal anesthesia: 1st minute,2nd minute, 3rd minute, 4th minute,5th minute,10th minute,15th minute, 20th minute, 25th minute, 30th minute, 60th minute, 90th minute, 120th minute, 150th minute, 180th minute, 210th minute |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Different traditional approaches are followed to reduce hypotension following spinal anaesthesia. However, those convers minimal advantage in some patients.
Latest guideline of the American Society of Echocardiography recommends the use of IVCCI in assessing volume status. In contrast to current traditional approaches, ultrasonographic assessment of the inferior vena cava collapsibility index (IVCCI) is simple, non-invasive, time-efficient, and easily available as well.
In this context, we aim to evaluate the correspondence of preoperative IVCCI and the incidence of intraoperative hypotension following spinal anaesthesia. |