NCT01176539

Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor

How Does the New Kai R Spot 100 Respiratory Monitor Compare to the Currently Used Respiratory Monitor for Measuring Respiratory Rate During Overnight Sleep Studies?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Kai Medical, Inc. · Industry
• Sex: All
• Age: 29 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the respiratory rate provided by Kai Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the currently used methods, including respiratory chest bands.

Conditions

• Respiration

Interventions

Type	Name	Description
DEVICE	Non-Contact Respiratory Rate Monitor	The Non-Contact Respiratory Rate Monitor provides a measurement of respiratory rate at a single point in time for neonates, pediatrics and adults. The Non-Contact Respiratory Rate Monitor provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults.

Timeline

• Start date: 2010-03-01
• Completion: 2011-03-01
• First posted: 2010-08-06
• Last updated: 2011-06-08

Locations

1 site across 1 country: United States