| CTRI Number |
CTRI/2024/12/077650 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Observation of low blood pressure under general anaesthesia by measurerment of subclavian vein diameter changes with the help of ultrasound |
|
Scientific Title of Study
|
Ultrasound Guided Subclavian vein Diameter indices as Predictors of Hypotension in Patients after Induction of General Anesthesia A Prospective Observational 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 Harekrushna Jena |
| Designation |
Junior Resident in Department of anesthesiology |
| Affiliation |
Veer Surendra Sai Institute of Medical Sciences And Research BURLA |
| Address |
Department of anesthesiology, Veer Surendra Sai Institute of Medical Science and Research, Burla, Sambalpur
Sambalpur
ORISSA
768017
India |
| Phone |
8093341824 |
| Fax |
|
| Email |
hkjena1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dulal Kishun Soren |
| Designation |
Professor Department of anesthesiology |
| Affiliation |
Veer Surendra Sai Institute of Medical Sciences And Research BURLA |
| Address |
Department of anesthesiology VIMSAR Burla
Sambalpur
ORISSA
768017
India |
| Phone |
8093341824 |
| Fax |
|
| Email |
dulalsoren@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dulal Kishun Soren |
| Designation |
Professor Department of anesthesiology |
| Affiliation |
Veer Surendra Sai Institute of Medical Sciences And Research BURLA |
| Address |
Department of anesthesiology VIMSAR Burla
Sambalpur
ORISSA
768017
India |
| Phone |
8093341824 |
| Fax |
|
| Email |
dulalsoren@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Veer Surendra Sai Institute of Medical Sciences And Research
Burla
Pincode 768017
Sambalpur
Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Harekrushna Jena |
| Address |
Department of Anaesthesiology
Veer Surendra Sai Institute of Medical Sciences And Research
Burla
PIN code 768017
Sambalpur
Odisha
|
| Type of Sponsor |
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 |
| Harekrushna Jena |
VEER SURENDRA SAI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
Department of Anesthesiology and
Critical Care VIMSAR Burla
Sambalpur
ORISSA |
08093341824
hkjena1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VEER SURENDRA INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex with bmi less than 25 undergoing elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients refusal
Emergency Surgery
Peripheral vascular disease
Cardiovascular disease
Cardiopulmonary complication
Circulatory Instability |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subclavian Vein diameter indices can predict the occurrence of hypotension after induction of general anesthesia |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Collapsibility index of subclavian vein and prediction of intra operative hypotension are correlated |
2 years |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
30/01/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Nearly one third intraoperative hypotension cases occurred between induction of anesthesia and surgical incision. Therefore, anesthesiologist should pay special attention to the occurrence of hypotension. Ultrasound scanning of subclavian vein and measurement of the collapsibility index preoperatively provides a reliable predictor of hypotension after induction of general anesthesia . Thus in patients at high risk of complications resulting from of hypotension, measurement of subclavian vein collapsibility index may provide clinically useful information. |