| CTRI Number |
CTRI/2024/04/065526 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To know which is better predicting hypotension after general anaesthesia, before operation An observational study. |
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Scientific Title of Study
|
Preoperative ultrasonographic evaluation of inferior vena cava collapsibility index versus subclavian vein collapsibility index as a predictor of hypotension following induction of general anaesthesia:An observational study |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagashree j bharadwaj |
| Designation |
Assistant professor |
| Affiliation |
Dr.B.R.Ambedkar medical college and hospital |
| Address |
Department of anaesthesiology,DR.B.R.Ambedkar medical college and hospital,KG Halli, bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
7795581454 |
| Fax |
|
| Email |
nagashree.brj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagashree j bharadwaj |
| Designation |
Assistant professor |
| Affiliation |
Dr.B.R.Ambedkar medical college and hospital |
| Address |
Department of anaesthesiology,DR.B.R.Ambedkar medical college and hospital,KG Halli, bangalore
KARNATAKA
560045
India |
| Phone |
7795581454 |
| Fax |
|
| Email |
nagashree.brj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShantha |
| Designation |
2nd yr post graduate |
| Affiliation |
Dr.B.R.Ambedkar medical college and hospital |
| Address |
Department of anaesthesiology,DR.B.R.Ambedkar medical college and hospital,KG Halli, bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
6360119064 |
| Fax |
|
| Email |
poojarishanta1994@gmail.com |
|
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Source of Monetary or Material Support
|
| Dr.B.R.Ambedkar medical college and hospital,bengaluru |
|
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Primary Sponsor
|
| Name |
DrNagashree j bharadwaj |
| Address |
Department of anaesthesiology,Dr.B.R.Ambedkar medical college and hospital,bangalore |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nagashree J Bharadwaj |
Dr.B.R.Ambedkar medical college and hospital |
OT complex, KG Halli,Bangalore-560045
Bangalore
KARNATAKA |
7795581454
nagashree.brj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committe Dr.B.R.Ambedkar medical college and hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for elective surgery under general anaesthesia
2.age between 18 to 60 years
3.American Society of Anaesthesiologists physical status(ASA-PS)Class 1 and 2 patients |
|
| ExclusionCriteria |
| Details |
1.Peripheral vascular disease.
2.Patients with hypovolemia or hypervolemia.
3.Circulatory instability.
4.Patients on ACEI and ARBs.
5.BMI more than 35kg/m2 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the inferior vena cava collapsibility index and subclavian vein collapsibility index for detection of hypotension following induction of general anaesthesia |
preoperatively first 10min before intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out the rate of change of subclavian vein diameter collapsibility index (DSCV-CI) and inferior vena cava collapsibility index (DIVC-CI) in supine and with passive leg raising (PLR)
2.To evaluate the time taken to obtain data from IVC and SVC.
3.To evaluate other haemodynamic parameters following induction of general anaesthesia. |
preoperatively and first 10 mins after the induction of general anaesthesia |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/05/2024 |
| 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="0"
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
|
Hypotension is very common intraoperatively in patients under anaesthesia and may cause many adverse effects which leads to extended hospital stay of patients.[1] After induction of general anaesthesia, patients are at particular risk of developing hypotension because of the cardiovascular depressant and vasodilatory effects of anaesthetic agents more seen in patients with hypovolemia and lack of compensatory response.[2].Other factors include American Society of Anaesthesiologists physical status (ASA) III and IV, baseline mean arterial pressure lower than 70 mmHg, age more than 60 years, use of propofol, and high fentanyl dose [3]. Preoperative volume status depends on various factors like physical status, comorbidities, bowel preparation and fasting period of patient[2]. Intra operative hypotension may lead to adverse events like myocardial infarction, heart failure, stroke, acute renal failure, prolonged hospital stay, increased mortality[2]. Assessing intravascular volume status is a challenge for clinicians. Traditional static parameters like central venous pressure are invasive and not accurate. Ultrasound assessment of inferior vena cava diameter (DIVC) with respiration, passive leg raise test and IVC collapsibility index (IVC-CI) are used as a reliable, non invasive tool to assess intravascular volume and predict intraoperative hypotension.[1,3,4,5] But IVC assessment is difficult in patients having abdominal distension, tenderness, guarding, ascites, morbid obesity and patients having abdominal dressing. [2] Hence Subclavian vein (SCV) which is located adjacent to the pleura and upstream of the superior vena cava can be easily visualized in most patients with a linear probe.[2] Studies have shown that SCV assessment can be used as reliable adjust to IVC for measurement of intravascular volume status[1,2,4]. Also, Collapsibility Index of Subclavian Vein (SCV-CI) was able to predict post general anaesthesia hypotension in deep inspiration[1]. We hypothesize that pre operative ultrasonographic SCV-CI is a reliable and a better alternative to IVC-CI in predicting hypotension following induction of general anaeasthsia. |