| CTRI Number |
CTRI/2022/05/042810 [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 SkanRespiro Plus and Pranaa |
|
Scientific Title of Study
|
A prospective, post market, non-interventional observational, open label, single arm, single center study to confirm clinical safety and performance of SkanRespiro Plus and Pranaa |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3-75-010-0115-21 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
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
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 |
Plot No. 15-17, Hebbal Industrial Area Mysore
Mysore
KARNATAKA
570016
India |
| Phone |
9844761818 |
| Fax |
|
| Email |
vasundhara.r@skanray.com |
|
|
Source of Monetary or Material Support
|
| Skanray Technologies Limited
Plot # 15-17, Hebbal Industrial Area, Mysore - 570015 |
|
|
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 - 560099
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: J069||Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: J953||Chronic pulmonary insufficiency following surgery, (3) ICD-10 Condition: J709||Respiratory conditions due to unspecified external agent, (4) ICD-10 Condition: J969||Respiratory failure, unspecified, (5) ICD-10 Condition: J689||Unspecified respiratory conditiondue to chemicals, gases, fumes and vapors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
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.
Subjects who need mechanical ventilation.
Subject or the legally authorised representative on behalf of 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.
Subjects who need ventilation during transport.
Pregnant or nursing mother.
Unconscious subjects shall be excluded from the non invasive mode of ventilation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition. |
Every 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Collection of feedback which includes investigator’s assessment of the overall safety and performance of the SkanRespiro Plus and Pranaa.
Collection of feedback from the user reflecting the ease of ventilation and usability.
The collection of evidence reflecting the subject ventilation
|
Every seventh day or earlier |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SkanRespiro Plus is a paediatric and adult critical care ventilator intended to provide short term continuous mechanical ventilation. It is capable of delivering pneumatically induced breaths based on set parameters and proactively monitors respiratory parameters. Pranaa is a medical air compressor which acts as an accessory for ICU or anesthesia ventilator. It provides the dry, compressed and filtered air to the ventilator. This clinical study is being conducted to confirm the clinical safety and performance of SkanRespiro Plus and Pranaa. This study will generate the clinical evidence to support the claimed intended use.
|