Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-03 @ 2:19 AM
Study NCT ID:
NCT05246358
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2022-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Rate Validation Study - ChroniSense Polso
Sponsor:
ChroniSense Medical Ltd.
Organization:
Study Overview
Official Title:
Respiratory Rate Validation Study - ChroniSense Polso
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso
Detailed Description:
20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso.
A range of stable respiratory rates were elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.
Each subject was instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor was used as the Accuracy Reference Device (Reference) in this study.
A range of stable respiratory rates were elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.
Each subject was instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor was used as the Accuracy Reference Device (Reference) in this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: