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

• Conditions: Respiration
• Interventions: Device: Kai Spot (v 2.1); Device: Kai Continuous (v 1.0)

• Registration Number: NCT01324817
• Lead Sponsor: Kai Medical, Inc.

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-26
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-12
• Last Update Posted: 2011-12-14
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hopitalized	Kai Spot (v 2.1)	Patients admitted to the hospital
Hopitalized	Kai Continuous (v 1.0)	Patients admitted to the hospital

Trial Locations

Locations (1)

Kapiolani Medical Center for Women and Children; 🇺🇸 Honolulu, Hawaii, United States