NCT03750344

ChroniSense Polso Wrist Worn Respiration Rate Validation Study

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

Summary

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system

Detailed description

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system. A range of stable respiratory rates will be 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 will be 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 will be used as the Accuracy Reference Device (Reference) in this study.

Conditions

• Respiratory Rate

Interventions

Type	Name	Description
DEVICE	Diagnostic test	Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed

Timeline

• Start date: 2018-11-06
• Primary completion: 2018-11-09
• Completion: 2018-11-30
• First posted: 2018-11-23
• Last updated: 2019-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study