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

December 12, 2011 updated by: Kai Medical, Inc.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates hospitalized at the Kapiolani Medical Center for Women and Children located in Honolulu, HI

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hopitalized
Patients admitted to the hospital
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.
Other Names:
  • Kai Spot
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.
Other Names:
  • Kai Continuous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kai Medical, Inc.

Investigators

  • Principal Investigator: Venkataraman Balaraman, MD, Kapiolani Medical Center For Women & Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

March 26, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 14, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KAI-00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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