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Spire Medical Health Tag Respiratory Rate Validation in Adults

NCT04104737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-10-30

No results posted yet for this study

Summary

The primary purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Spire Medical Health Tag to a FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).

After IRB approval, a minimum of 20 healthy volunteer test subjects, 18 or older will be entered into this study designed to validate the accuracy of the respiratory rate feature of the Spire Medical Health Tag (Device Under Test).

The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMIs. Each subject will be connected to a FDA cleared EtCO2 monitor (GE Datex-Ohmeda) and will be instrumented with a mouthpiece or open system mask that allows for measurement of EtCO2 derived respiratory rate. A range of stable respiratory rates will be elicited from each volunteer test subject with the use of a paced breathing application on a mobile phone. Subjects will also be connected to a 3-lead ECG (GE Datex-Ohmeda) for the purpose of monitoring heart rate and comparing to the pulse rate measurements recorded by the Spire Medical Health Tag.

The respiratory rate and pulse rate will be measured simultaneously for the Reference and the Device Under Test.

Conditions

  • Respiratory Rate

Interventions

DEVICE

Spire Medical Health Tag

Collect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2. A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3- lead ECG will be used for the Respiratory and Pulse Rate References.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Spire, Inc.

    lead INDUSTRY

Principal Investigators

  • Dena Raley, BS · CTO Clinimark LLC.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2019-06-13
Completion
2019-06-13
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 NCT04104737 on ClinicalTrials.gov