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

Kai Medical

Status: Unknown

Conditions: Respiration

Treatments: Device: Kai Continuous (v 1.0); Device: Kai Spot (v 2.1)

Study type: Observational

Funder types: Industry

Identifiers

NCT01324817

KAI-00006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

50 participants in 1 patient group

Hopitalized

Description:

Patients admitted to the hospital

Treatment:

Device: Kai Spot (v 2.1)

Device: Kai Continuous (v 1.0)