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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01324817
Enrollment
50
Registered
2011-03-29
Start date
2011-01-31
Completion date
2012-03-31
Last updated
2011-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration

Keywords

Non-Contact, Radar, Doppler, Respiratory, Respiration, Breathing, Rate, Frequency, Respiratory Mechanics, Respiratory Rate Measurement, Apnea, Sleep Apnea

Brief 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.

Interventions

DEVICEKai 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.

DEVICEKai 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.

Sponsors

Kai Medical, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
Yes

Inclusion criteria

* Inclusion Criteria: 1\. Clinically stable *

Exclusion criteria

1\. Clinically unstable * Hypotensive requiring pressors * Intubated 2\. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.

Countries

United States

Contacts

Primary ContactVenkataraman Balaraman, MD
VBalaraman@kapiolani.org808-983-6718

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026