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Bora Band Respiration Rate Study

NCT04064645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-08-22

No results posted yet for this study

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.

Conditions

  • Respiratory Rate

Interventions

DEVICE

Measurement of respiratory rate with DUT and comparison with reference

The subject will follow the paced breathing app, once a stable Respiration Rate at the natural rate (without the breathing app) is captured. The breathing pattern on the app will be set to begin near the normal Respiration Rate of the subject and continue to go down by five intervals until reaching the Respiration Rate of 5 bpm. After that, we will pick back up at the rate above the subject's normal Respiration Rate and continue upwards until reaching 50 bpm or as high as the subject can tolerate up to 50 bpm. The respiratory rate will be monitored simultaneously with an EtCo2 (Reference) and the BORA BAND™ wristband monitoring system, Device Under Test. These data will be continuously recorded electronically. Additional study notes that describe conditions of the test as well as deviations, device issues and any adverse events will be recorded in written documentation.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Biosency

    lead INDUSTRY

Principal Investigators

  • Arthur Cabrera, MD · Clinimark, LLC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2019-07-25
Completion
2019-07-25
FDA Device
Yes

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 NCT04064645 on ClinicalTrials.gov