| CTRI Number |
CTRI/2024/10/074900 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
To compare IVC changes and brachial artery velocity changes with and without raising legs in healthy patients undergoing general anaesthesia to better predict hypotension |
|
Scientific Title of Study
|
A comparative study of inferior vena cava collapsibility index and brachial artery peak systolic flow velocity variation with passive leg raising in predicting hypotension after induction of general anaesthesia. |
| 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 Sheen Bhat |
| Designation |
Junior Resident |
| Affiliation |
KLE Dr Prabhakar Kore Hospital |
| Address |
Department Of Anaesthesiology,Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9145069660 |
| Fax |
|
| Email |
sheen.bhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath C Patil |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital |
| Address |
Department Of Anaesthesiology,Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath C Patil |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital |
| Address |
Department Of Anaesthesiology,Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College - Belagavi |
|
|
Primary Sponsor
|
| Name |
Sheen Bhat |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital
and Medical Research Centre, Jawaharlal Nehru Medical College
campus, Nehru Nagar, Belagavi, Karnataka |
| Type of Sponsor |
Other [Other (Self)] |
|
|
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 Sheen Bhat |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College Campus
Belgaum
KARNATAKA |
9145069660
sheen.bhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give consent
Patients posted for elective surgeries under GA
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
All patients undergoing emergency surgeries
All patients who are unwilling to give consent
All patients requiring rapid sequence intubation
All patients experiencing extended airway instrumentation due to difficult intubation
All patients on vasopressor drugs to maintain MAP more than 65 mm Hg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare IVC collapsibility index and brachial artery peak systolic flow velocity with passive leg raising in predicting hypotension after induction of general anaesthesia |
baseline,induction,2 minutes,4 minutes,6 minutes,8 minutes,incision |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
17/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/10/2024 |
| 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 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
|
Induction of general anaesthesia is often associated with hypotension and is a common scenario faced by anaesthesiologists .The degree of hypotension can depend on age, comorbidities and anaesthetic drugs used during general anaesthesia.Patient’s pre induction volume status can have an effect on post induction hypotension considering long periods of fasting for elective surgeries.The role of IVC measurements in predicting hypotension has been studied previously and found to be useful in critical care and peri operative period.Peak systolic flow velocity in the major arteries like the carotid artery and limb arteries vary with the intravascular volume status , with peak systolic flow velocity increasing with increase in intravascular volume .In recent studies , increase in peak systolic flow velocity of more than 10% after passive leg raising compared to supine position in critically ill patients has been found to be a reliable indicator of hypovolemia and hence helpful in predicting volume responsiveness . Also it can be used when screening IVC is difficult.Hence in this study we try to compare IVC Collapsibility index with brachial artery peak systolic flow velocity variation with passive leg raising in predicting hypotension after induction with general anaesthesia
|