NCT01324817

Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Kai Medical, Inc. · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.

Detailed description

The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to: 1. Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use. 2. Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems. 3. Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.

Conditions

• Respiration

Interventions

Type	Name	Description
DEVICE	Kai Spot (v 2.1)	The Kai Spot (v 2.1) provides a measurement of respiratory rate at a single point in time for neonates, pediatrics, and adults.
DEVICE	Kai Continuous (v 1.0)	The Kai Continuous (v 1.0) 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: 2011-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-03-29
• Last updated: 2011-12-14

Locations

1 site across 1 country: United States