NCT05246358

Respiratory Rate Validation Study - ChroniSense Polso

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ChroniSense Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 52 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Rate

Interventions

Type	Name	Description
DEVICE	ChoniSense Polso	A range of stable respiratory rates was elicited from each volunteer test subject. The rates were 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.

Timeline

• Start date: 2021-05-10
• Primary completion: 2021-05-14
• Completion: 2021-06-11
• First posted: 2022-02-18
• Last updated: 2022-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study