Bora Band Respiration Rate Study

Status Completed

Clinical Trial Summary

The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the BORA BAND™ Wristband Monitoring System to the Reference. Respiratory Rate will be compared to an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). The testing will be conducted in two phases. The first phase will be an initial data collection to assist in the algorithm development of respiration rate. Upon a successful Phase one performance, the second phase will be the Respiratory Rate Validation conducted at a different period in time.

Clinical Trial Description

For phase 1, there will be 5 to 6 volunteer test subjects. For the final validation phase, there will be a minimum of 20 volunteer test subjects. All subjects will be 18 or older and selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.

Each subject will be connected to a commonly used, FDA cleared ECG Impedance monitor (to be used for informational purposes) and an End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and BiOSENCY BORA BAND™ wristband monitoring system. The end tidal CO2 monitor will be attached to the patient to determine performance of respiratory rate metrics (Reference). Each subject will be instrumented with a mouthpiece that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate (Reference) and tidal volume.

A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40, 45 and 50 breaths per minute; with some natural variation from these exact numbers. Paced breathing app will be used. Not all subjects will be able to breathe at a constant level for every rate.

The respiratory rate will be measured simultaneously with EtCO2 (Reference) and the Devices Under Test.

For the data analysis, the EtCO2 monitor will be used to assess the stability of the data. If the respiratory rate varies by more than +3 bpm during a one-minute period of the target respiration rates, then the data for that period will be considered unstable and removed from analysis.

To 'Pass' this test the BiOSENCY BORA BAND™ wristband (Device Under Test) must demonstrate a Respiratory Rate of ≤3 when compared to the Reference End tidal carbon dioxide monitor. ;

Study Design

Related Conditions & MeSH terms

Respiratory Rate

Clinical Trial Details

NCT number	NCT04064645
Study type	Interventional
Source	Biosency
Contact
Status	Completed
Phase	N/A
Start date	June 25, 2019
Completion date	July 25, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.