| CTRI Number |
CTRI/2022/07/043899 [Registered on: 11/07/2022] Trial Registered Prospectively |
| Last Modified On: |
14/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of infraclavicular axillary vein using ultrasonography before anesthesia and predicting decrease in blood pressure after giving general anesthesia |
|
Scientific Title of Study
|
PREANAESTHETIC ULTRASONOGRAPHIC MEASUREMENT OF RIGHT INFRACLAVICULAR AXILLARY VEIN FOR PREDICTING HYPOTENSION AFTER INDUCING GENERAL ANAESTHESIA– A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUBHA R |
| Designation |
Associate professor, Department of Anaesthesiology,Reginal cancer centre , Thiruvananthapuram |
| Affiliation |
Regional cancer centre |
| Address |
Regional cancer centre
Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446700525 |
| Fax |
|
| Email |
drsubharcc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUBHA R |
| Designation |
Associate professor, Department of Anaesthesiology,Reginal cancer centre , Thiruvananthapuram |
| Affiliation |
Regional cancer centre |
| Address |
Regional cancer centre
Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446700525 |
| Fax |
|
| Email |
drsubharcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haseena A N |
| Designation |
Junior Resident, Department of Anaesthesiology,Reginal cancer centre , Thiruvananthapuram |
| Affiliation |
Regional cancer centre |
| Address |
Regional cancer centre
Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8281792484 |
| Fax |
|
| Email |
haseenanaushad252@gmail.com |
|
|
Source of Monetary or Material Support
|
| REGIONAL CANCER CENTRE
THIRUVANATHAPURAM |
|
|
Primary Sponsor
|
| Name |
Regional Cancer Centre |
| Address |
Regional Cancer Centre
Thiruvananthapuram |
| Type of Sponsor |
Research institution and hospital |
|
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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 SUBHA R |
REGIONAL CANCER CENTRE |
Operation theatre complex
Department of anesthesiology
Regional Cancer Centre
Thiruvananthapuram
KERALA |
9446700525
drsubharcc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN ETHICS COMMITTEE REGIONAL CANCER CENTRE THIRUVANANTHAPURAM |
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: C029||Malignant neoplasm of tongue, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 19 to 60 years , with American society of anaesthesiology (ASA) 1 and 2 statuses coming for elective surgery under General
anaesthesia(GA) with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Patients who refuse participate, requirement for vasopressors to maintain a mean arterial blood pressure (MAP) greater than 65 mmHg, baseline
MAP less than 70 mmHg, the proximal and /or distal axillary vein not clearly visualized , fracture of ipsilateral clavicle or anterior proximal ribs, axillary vein thrombosis, presence of major peripheral vascular disease, severe vascular
disease, unstable angina, respiratory distress, implanted pacemaker/cardioverter, mental incompetence, tricuspid failure, right-sided heart disease, portal hypertension, increased intra-abdominal pressure or expectation of difficult
intubation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the association between preoperative infraclavicular axillary vein measurement and change in BP
2. To predict the incidence of intraoperative hypotension and percentage decrease in Mean arterial pressure |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative major cardiovascular events and associated mortality and morbidity |
1 year |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/08/2022 |
| 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
|
Choi, Min Hee; Chae, Ji Seon; Lee, Hyun Jung; Woo, Jae Hee Pre-anaesthesia ultrasonography of the subclavian/infraclavicular axillary vein for predicting
hypotension after inducing general anaesthesia, European Journal of
Anaesthesiology: June 2020 - Volume 37 - Issue 6 - p 474-481
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Induction of anesthesia is associated with risk of hypotension as anesthetic agents have cardiovascular depressant and vasodilatory effects . Ultrasound examination of inferior venacava in patients with spontaneous respiration has been recommended as anon invasive method for estimation of volume status .However IVC assessment has limitations in patients with abdominal distension and tenderness. In this study we intend to measure the preoperative diameter and collapsibility index of right infraclavicular axillary vein during spontaneous breathing and deep inspiration and then examine whether these parameters could predict hypotension after induction of general anesthesia |