Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Remote Doppler System to Measure Heart Rate and Breathing Pattern|
|Study Start Date:||January 2009|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827905
|United States, Hawaii|
|The Queen's Medical Center|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Todd Seto, MD||The Queen's Medical Center|
|Study Director:||Olga Boric-Lubecke, PhD||University of Hawaii|