| CTRI Number |
CTRI/2022/05/042811 [Registered on: 25/05/2022] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post Market Clinical Follow Up of Skanray s Patient Monitors |
|
Scientific Title of Study
|
A prospective, post market, non-interventional observational, open label, single arm, single center study to confirm the clinical safety and performance of Skanray’s Patient Monitors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3-99-010-0025-57 Version 01 Date 05 Jan 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chethan Sadashivappa |
| Designation |
Consultant |
| Affiliation |
Narayana Health MICU Mazumdar Shaw Medical Center |
| Address |
Narayana Health MICU Mazumdar Shaw Medical Center, 258/A, Bommasandra Industrial Area, Hosur Road Anekal Taluk
Bangalore
KARNATAKA
560099
India |
| Phone |
9599204215 |
| Fax |
|
| Email |
chethananudeeps@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chethan Sadashivappa |
| Designation |
Consultant |
| Affiliation |
Narayana Health MICU Mazumdar Shaw Medical Center |
| Address |
Narayana Health MICU Mazumdar Shaw Medical Center, 258/A, Bommasandra Industrial Area, Hosur Road Anekal Taluk
Bangalore
KARNATAKA
560099
India |
| Phone |
9599204215 |
| Fax |
|
| Email |
chethananudeeps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasundhara R |
| Designation |
Head - Regulatory Affairs |
| Affiliation |
Skanray Technologies Limited |
| Address |
Skanray Technologies Limited Plot No. 15-17, Hebbal Industrial Area Mysore
Mysore
KARNATAKA
India
Mysore
KARNATAKA
570016
India |
| Phone |
9844761818 |
| Fax |
|
| Email |
vasundhara.r@skanray.com |
|
|
Source of Monetary or Material Support
|
| Skanray Technologies Limited |
|
|
Primary Sponsor
|
| Name |
Skanray Technologies Limited |
| Address |
Plot # 15-17, Hebbal Industrial Area, Mysore - 570015 |
| Type of Sponsor |
Other [[Medical Device Manufacturer]] |
|
|
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 Chethan Sadashivappa |
Narayana Health Mazumdar Shaw Medical Center |
258/A, Bommasandra Industrial Area, Hosur Road Anekal Taluk
Bangalore
KARNATAKA |
9599204215
chethananudeeps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethis Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult, pediatric and neonatal subjects of either genders.
The patients who need continuous physiological parameters monitoring in different areas of the hospital (Ex; ICU, OT, emergency, wards, operative care etc.)
The subjects or the legally authorised representative capable of understanding and signing the informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects who are to be monitored in an MRI environment or in an oxygen-enriched environment.
Neonates shall be excluded for ST segment and arrhythmia analysis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Continuous monitoring of vital physiological parameters such as ECG 3 5 12 lead, arrhythmia & ST analysis, respiration rate, non invasive blood pressure, invasive blood pressure, temperature, SpO2, end tidal CO2, cardiac output, non-invasive cardiac output and anesthesia gas monitoring. |
Every 1 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Collection of feedback reflecting the usability and design features from users.
Collection of evidence reflecting the monitored parameters.
|
Every 7th day or earlier |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/06/2022 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Skanray’s Patient monitoring system are multi-parameter semi-modular patient monitoring system for continuous monitoring of the physiological parameters such as electrocardiogram, ST analysis, Respiration rate, Temperature, Non invasive blood pressure, Oxygen saturation (SpO2), Invasive blood pressure, End tidal carbon dioxide, Cardiac output, Non invasive cardiac output & Anesthesia gas monitoring. The purpose of this study is to confirm the clinical safety and performance of Skanray’s Patient monitoring systems. This study will generate the clinical evidence to support the claimed intended use. |