| CTRI Number |
CTRI/2022/05/042858 [Registered on: 27/05/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Clinical Study of Skanrays Anesthetic Workstations |
|
Scientific Title of Study
|
A prospective, cross sectional, open label, single arm, non-randomised clinical study to confirm clinical safety and performance of Skanray’s Anesthetic Workstations |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3-75-010-0118-12 Version 01 Date 05 Jan 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muralidhar Kanchi |
| Designation |
Senior Consultant - Anesthesia |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
Narayana Institute of Cardiac Sciences, 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bangalore
KARNATAKA
560099
India |
| Phone |
9980163108 |
| Fax |
|
| Email |
muralidhar.kanchi.dr@narayanahealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muralidhar Kanchi |
| Designation |
Senior Consultant - Anesthesia |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
Narayana Institute of Cardiac Sciences, 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bangalore
KARNATAKA
560099
India |
| Phone |
9980163108 |
| Fax |
|
| Email |
muralidhar.kanchi.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Vasundhara R |
| Designation |
Head - Regulatory Affairs |
| Affiliation |
Skanray Technologies Limited |
| Address |
Skanray Technologies Limited, Plot # 15-17, Hebbal Industrial Area
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
|
| Name |
Address |
| Skanray Technologies Limited |
Plot # 15-17, Hebbal Industrial Area, Mysore - 570015 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Muralidhar Kanchi |
Narayana Institute of Cardiac Sciences |
Narayana Institute of Cardiac Sciences, 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bangalore
KARNATAKA |
9980163108
muralidhar.kanchi.dr@narayanahealth.org |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult and pediatric subjects of age more than two year or body weight of 10 kg above whichever is lower and of either gender.
Subject or the legally authorised representative on behalf of the subject shall be capable of understanding and signing the informed consent form. |
|
| ExclusionCriteria |
| Details |
Subjects with age less than two year or less than 10 kg of body weight |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determining the safety and performance in terms of delivered parameters against the intended or set values for the specific subject condition. The ventilatory, vital physiological and anesthesia gas monitoring parameters should be evaluated. |
For 60 minutes surgery: 0,12,24,36,48,60th minute.
For 120 minutes surgery: 0,24,48,72,96,120th minute.
For 360 minutes surgery: 0, 36,72,108,144,180 minute. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Collection of feedback from the user /investigator reflecting the ease of delivering the anesthetic gas mixture, ventilatory support and usability.
Collection of feedback which includes the investigators assessment of the overall safety and performance of the Skanray’s Anesthetic Workstations.
The collection of evidence reflecting the delivery of anaesthetic gas mixture and ventilatory support.
|
Within 7 days after completing the general anesthesia procedure. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| Date of Study Completion (India) |
02/11/2022 |
| 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
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This clinical study aims to evaluate the safety and performance of Skanray Anesthetic Workstations in delivering precise oxygen-anesthetic gas mixtures and providing mechanical ventilation support during surgical procedures. The prospective, single arm study will assess whether the workstation meets its intended clinical use parameters for patients aged 2 years and above (equal or more than 10kg body weight). By documenting operational performance against set values and collecting user feedback, the study seeks to generate clinical evidence supporting the devices safety and performance in routine anesthesia practice. A total 15 subjects were enrolled in the pilot phase (NHMEC Ref no. S110/2022) the study was closed. The pilot phase report and closeout annexure were submitted. following an upgrade in the Skanray anesthetic workstation a new study was initiated and registered under CTRI/2025/02/081197 on 24 February 2025 |