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

NCT01324817 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2011-12-14

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Kai Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Venkataraman Balaraman, MD · Kapiolani Medical Center For Women & Children

Eligibility

Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01324817 on ClinicalTrials.gov