Spire Medical Health Tag Respiratory Rate Validation in Adults

NCT04104737 | Completed FDA Device

• 1 other identifier: PR 2019-330
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• measurement of respiratory rate to the Reference

  The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the Device Under Test (DUT) and the Reference EtCO2 (Ref) for all stable respiratory periods

  60 seconds

Study Arms (1)

Spire Medical Health Tag

EXPERIMENTAL

Spire Medical Health Tag is worn by all subjects The study is open label

Device: Spire Medical Health Tag

Interventions

Spire Medical Health Tag DEVICE

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.

Also known as: GE Healthcare S5 Multi-parameter monitoring system, End Tidal Carbon Dioxide (EtCO2), 3- lead ECG

Spire Medical Health Tag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have the ability to understand and provide written informed consent
• Subject is adult over 18 years of age
• Subject must be willing and able to comply with study procedures and duration
• Subject is a non-smoker
• Male or female of any race

You may not qualify if:

• Subject is considered as being morbidly obese (defined as BMI \>39.5)
• Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
• Subjects with known respiratory conditions such as:
• uncontrolled / severe asthma,
• flu,
• pneumonia / bronchitis,
• shortness of breath / respiratory distress,
• respiratory or lung surgery,
• emphysema, COPD, lung disease
• Subjects with self-reported heart or cardiovascular conditions such as:
• have had cardiovascular surgery
• Chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
• previous heart attack
• blocked artery

Sponsors & Collaborators

• Spire, Inc.: lead
• Clinimark, LLC: collaborator

Study Sites (2)

Spire, Inc.

San Francisco, California, 94110, United States

Location

Arthur Cabrera, MD.

Louisville, Colorado, 80027, United States

Location

Study Officials

• Dena Raley, BS

  CTO Clinimark LLC.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: June 4, 2019
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)