Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check

This study has been completed.
Sponsor:
Information provided by:
Kai Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00827905
First received: January 21, 2009
Last updated: August 4, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to determine whether the respiratory rate provided by the Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal XactTrace respiratory effort sensor and Somnologica for Embletta software.


Condition Intervention
Respiration
Device: RSpot Non-Contact Respiratory Rate Spot Check

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Remote Doppler System to Measure Heart Rate and Breathing Pattern

Resource links provided by NLM:


Further study details as provided by Kai Medical, Inc.:

Estimated Enrollment: 20
Study Start Date: January 2009
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hospitalized
Patients admitted to the hospital
Device: RSpot Non-Contact Respiratory Rate Spot Check
The Kai Sensors RSpot 100 provides a measurement of respiratory rate at a single point in time. It uses a low-power radar to detect respiratory effort, and analyzes the respiratory effort signal to provide a respiratory rate.
Other Names:
  • KaiSpot
  • RSpot 100
  • RSpot
  • Non-Contact Respiratory Rate Spot Check

Detailed Description:

Currently, medical professionals obtain respiratory rate for vital signs assessments either by counting the number of breaths during a 15, 30, or 60 second interval and multiplying to obtain breaths per minute, or by reading the respiratory rate off of a multiparameter vital signs monitor (such as a Welch Allyn Propaq Monitor), that provides respiratory effort information based on the change of AC impedance through ECG leads. The Respiration channel (RESP) of the Welch Allyn Propaq is intended to detect the rate or absence of respiratory effort, deriving the signal by measuring the AC impedance between the selected terminals of the ECG electrodes. The RSpot 100 Non-Contact Respiratory Rate Spot Check provides an alternative to the medical professional counting respiratory rate or reading the rate from a vital signs monitor designed for continuous respiratory rate monitoring. The Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is used for a one-time measurement of respiratory rate as part of a vital signs assessment in the hospital or other clinical settings.

In this study, the RSpot is operated simultaneously with two other systems that provide a respiratory rate: Welch Allyn Propaq Encore model 242 and Embletta system with Universal XactTrace and Somnologica software. A respiratory rate is also obtained by counting respiratory excursions for the same duration as the RSpot measurement interval, 15, 30, or 60 seconds. The rates obtained from each of the four measurement methods are then compared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients Hospitalized at the Queen's Medical Center in Honolulu, HI

Criteria

Inclusion Criteria:

  • Adult >18 years old
  • Hospitalized on Tower 6 or Pauahi 6 or Pauahi 4
  • Clinically stable
  • Able to provide informed consent

Exclusion Criteria:

  • Clinically unstable

    1. Hypotensive requiring pressors or intra-aortic balloon pump
    2. Intubated
    3. Dyspnea or chest pain at rest
    4. Resting tachycardia (heart rate >100 bpm)
    5. Requires supplemental (e.g., nasal canula or face mask) oxygen
  • Scheduled or planned (e.g., CT scan, central line placement) procedure during the 30 minute study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827905

Locations
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Kai Medical, Inc.
Investigators
Principal Investigator: Todd Seto, MD The Queen's Medical Center
Study Director: Olga Boric-Lubecke, PhD University of Hawaii
  More Information

No publications provided

Responsible Party: Amy Droitcour, Director of Technology, Kai Medical, Inc.
ClinicalTrials.gov Identifier: NCT00827905     History of Changes
Other Study ID Numbers: KAI-00003, RA-2008-061
Study First Received: January 21, 2009
Last Updated: August 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Kai Medical, Inc.:
Non-Contact
Radar
Respiratory
Respiration
Breathing
Rate
Frequency
Respiratory Mechanics
Respiratory Rate Measurement

ClinicalTrials.gov processed this record on April 23, 2014