Respiration Clinical Trial
Official title:
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
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.
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.
;
Observational Model: Case-Only, Time Perspective: Cross-Sectional
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