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

UnknownOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Respiration
Interventions
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.

DEVICE

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.

Trial Locations (1)

96826

RECRUITING

Kapiolani Medical Center for Women and Children, Honolulu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kai Medical, Inc.

INDUSTRY

NCT01324817 - Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates | Biotech Hunter | Biotech Hunter