| CTRI Number |
CTRI/2023/07/055069 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare Inferior Vena Cava Collapsibility Index (IVCCI) and standard blood pressure monitoring as a better guide to fluid management in post spinal anaesthesia hypotension |
|
Scientific Title of Study
|
Comparison of Inferior Vena Cava Collapsibility Index by Point of Care USG (POCUS) and Standard Haemodynamic Monitoring as a Guide to Fluid Management in Post Spinal Hypotension - A Randomised Controlled 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 Anindya Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
3rd Floor, Major OT, Department of Anaesthesiology, Bharati Hospital and Research Centre, Pune - 411043
3rd Floor, Department of Anaesthesiology, Bharati Hospital and Research Centre, Pune - 411043
Mumbai
MAHARASHTRA
411043
India |
| Phone |
9022733052 |
| Fax |
|
| Email |
anindyaagarwal23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhada Aphale |
| Designation |
Professor |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
3rd Floor, Major OT, Department of Anaesthesiology, Bharati Hospital and Research Centre, Pune - 411043
3rd Floor, Major OT, Department of Anaesthesiology, Bharati Hospital and Research Centre, Pune - 411043
Mumbai
MAHARASHTRA
411043
India |
| Phone |
9850968630 |
| Fax |
|
| Email |
shubhada.aphale@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anindya Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
3rd Floor, Major OT, Department of Anaesthesiology, Bharati Hospital and Research Centre, Pune - 411043
3rd Floor, Major OT, Department of Anaesthesiology, Bharati Hospital and Research Centre, Pune - 411043
Mumbai
MAHARASHTRA
411043
India |
| Phone |
9022733052 |
| Fax |
|
| Email |
anindyaagarwal23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre, Dhankawadi, Pune - 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research Centre |
| Address |
Bharati Hospital and Research Centre, Dhankawadi, Pune - 411043 |
| 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 |
| Dr Anindya |
Bharati Hospital and Research Centre |
3rd Floor, Major OT, Department of Anaesthesiology, Bharati Hospital and Research Centre, Dhankawadi, Pune - 411043
Pune
MAHARASHTRA |
9022733052
anindyaagarwal23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDU Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypotension after induction with spinal anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing the Inferior vena cava collapsibility index (IVCCI) with Systolic Blood Pressure (SBP) |
Comparing the Inferior vena cava collapsibility index (IVCCI) with Systolic Blood Pressure (SBP) at time points 0 15 30 45 60 minutes after induction with spinal anaesthesia to determine predictor value of IVCCI for hypotension |
| Comparator Agent |
Comparing the Mean Arterial Pressure with Systolic Blood Pressure (SBP) |
Comparing the MAP with SBP at time points 0 5 10 15 20 30 45 60 minutes after induction with spinal anaesthesia to determine predictor value of MAP for hypotension |
| Intervention |
Fluid bolus of ringer lactate (RL) by 5ml/kg body weight of patient if IVCCI is more than 40% |
Fluid bolus of ringer lactate (RL) by 5ml/kg body weight of patient if IVCCI is more than 40% as management for hypotension intra operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are undergoing infraumbilical surgery uncder central neuraxial blockade (CNB)
2. ASA I and ASA II patients
3. Patients with good IVC visualisation |
|
| ExclusionCriteria |
| Details |
1. Obstetric patients
2. BMI more than 30
3. Patients with pre-existing hypovolemia
4. Patients contraindicated for central neuraxial blockade |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of hypotension by measuring inferior vena cava collapsibility index(IVCCI) more than 40% |
Every 15 minutes for 1 hour after induction with spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the number of vasopressor doses or fluid boluses provided in case & control group to manage intra operative hypotension |
For 1 hour post induction with spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
21/07/2023 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [anindyaagarwal23@gmail.com].
- For how long will this data be available start date provided 05-07-2023 and end date provided 05-07-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Spinal anaesthesia is one of the most commonly used methods of anaesthesia for infra umbilical procedures. . While it has advantages such as a rapid onset of action and being relatively cost effective, the most common and immediate complications are hypotension and bradycardia. A reading of mean arterial pressure (MAP) less than 50 mmHg can be a significant cause of mortality and morbidity. Patients with inadequate volume reserve before the induction of anaesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Inferior vena caval ultrasound (IVCUS) is effective to assess fluid responsiveness in critical care patients and has been proposed as a tool for assessing responsiveness in routine patients as well.
The primary purpose of my study is to determine the efficacy of IVCCI in predicting this post spinal hypotension and managing the intra-operative fluid doses based on these values. The study will compare standard monitoring procedures i.e. Mean Arterial Pressure (MAP) with the IVCCI to determine which is more effective in predicting hypotension in these patients. The study will assess the incidence of post spinal hypotension in the standard monitoring group (control) and USG guided measurement group (case) and compare the values obtained along with effectiveness of fluid therapy and fluid responsiveness in both groups.
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