| CTRI Number |
CTRI/2024/06/068494 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of blood pressure monitoring on the upper arm and calf in patients under spinal anaesthesia |
|
Scientific Title of Study
|
A comparative evaluation of non-invasive blood pressure monitoring on the upper arm and calf in patients under subarachnoid block: A prospective observational study |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sushmitha R Shenoy |
| Designation |
Post graduate |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
department of Anaesthesia and Operation Theatre Technology
K.S Hedge medical academy
Deralakatte Post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886780234 |
| Fax |
|
| Email |
sushmisachin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murali Krishna V |
| Designation |
senior resident |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical Care , Justice K S Hegde Charitable Hospital
Nithayananda Nagar, Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845196030 |
| Fax |
|
| Email |
muralikrishna@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SUSHMITHA R SHENOY |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
DEPARTMENT OF ANAESTHESIA AND OT TECHNOLOGY
K S HEGDE MEDICAL ACADEMY NITHYANANDANAGAR, DERALAKATTE
MANGALURU
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886780234 |
| Fax |
|
| Email |
sushmisachin@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALURU |
|
|
Primary Sponsor
|
| Name |
KS HEGDE MEDICAL ACADEMY |
| Address |
Nithyanandanagar, Deralakatte Post, Mangaluru, KARNATAKA 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 MURALI KRISHNA V |
JUSTICE K S HEGDE CHARITABLE HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, DERALAKATTE, NITYANANDANAGAR, MANGALURU 575018
Dakshina Kannada
KARNATAKA |
9845196030
muralikrishna@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S HEGDE MEDICAL ACADEMY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
all adult patients undergoing surgery in supine position under subarchanoid block with an ASA grade I,II,III |
|
| ExclusionCriteria |
| Details |
patient refusal for the study,
obese patients BMI>30
pregnant ladies
patient with contraindications for BP monitoring on the arm or calf |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO OBSERVE THE BLOOD PRESSURE MEASUREMENTS IN THE UPPER ARM AND CALF IN TERMS OF SBP DBP MAP |
30 minutes in the intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE SIMILARITY BETWEEN ARM AND CALF BLOOD PRESSURE MEASUREMENTS OF THE PATIENT INTRAOPERATIVELY |
30 minutes in the intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/06/2024 |
| Date of Study Completion (India) |
07/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is conducted to understand the clinical similarity and relevance of blood pressure values between arm and calf .Blood pressure
monitoring plays an important role in intraoperative patient monitoring to
recognize and prevent spinal induced hypotension. Measurement of blood pressure
on the calf in the patients under subarachnoid block is more convenient as the
limb movement is restricted and motion artefact is prevented. Hence
this study involves observation of blood pressure on the calf and arm. |