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NCT01324817 Clinical Trial

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

Respiration Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01324817
Other study ID # KAI-00006
Secondary ID
Status Recruiting
Phase N/A
First received March 26, 2011
Last updated December 12, 2011
Start date January 2011
Est. completion date March 2012

Study information
Verified date December 2011
Source Kai Medical, Inc.
Contact Venkataraman Balaraman, MD
Phone 808-983-6718
Email VBalaraman@kapiolani.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 2 Months
Eligibility - 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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii

Sponsors (1)
Lead Sponsor Collaborator
Kai Medical, Inc.

Country where clinical trial is conducted

United States, 

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