Spire Medical Health Tag Respiratory Rate Validation in Adults

October 28, 2019 updated by: Spire, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to 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. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.

This study will focus on the respiratory rate, RR parameter. The Spire Medical Health Tag is investigational and has not been cleared by the FDA. The intended purpose of the device under test is spot-checking, non-invasive monitoring / logging of respiratory rate on humans. For this evaluation, the device will be run in a continuous data collection mode.

The study population will include 20 healthy competent adults, ages 18 years and older. The subject selection will be a mix of males and females with small to large physiques. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form and passing the health screening. Eligible subjects need to meet all of the inclusion criteria and none of the exclusion criteria for participation.

It is expected that the data collection will take approximately 4-7 days to complete. There is no additional followup required for the investigation.

The data from the Device Under Test will be collected on an application installed on the iOS or Android mobile device separate from the reference equipment.

Multi-parameter monitor used during the study to observe a subject's vital signs include ECG tracing, heart rate, respiratory rate, and EtCO2 with capnograph.

  • GE Healthcare S5 Compact Monitor, M-NESTPR module with ECG, and/or Multi-parameter monitor
  • Portable oxygen tank, mask and ambu bag
  • GE Healthcare (Datex-Ohmeda) 3900 TruTrak+ / OxyTip+ Oxy-F-UN or Oxy-AF Sensor and Oxy-OL3 cable (SpO2 monitoring)
  • Blood pressure cuff and stethoscope

Currently the FDA defines respiration rate devices as Class II devices. The Device Under Test in this study is considered non-significant risk device.

There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Spire, Inc.
    • Colorado
      • Louisville, Colorado, United States, 80027
        • Arthur Cabrera, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • unexplained shortness of breath
    • congestive heart failure (CHF)
    • history of stroke
    • transient ischemic attack
    • carotid artery disease
    • myocardial ischemia
    • myocardial infarction
    • cardiomyopathy

  • Self-reported health conditions as identified in the Health Assessment Form

    • diabetes,
    • uncontrolled thyroid disease,
    • kidney disease / chronic renal impairment,
    • history of seizures (except childhood febrile seizures),
    • epilepsy,
    • history of unexplained syncope,
    • recent history of frequent migraine headaches,
    • recent head injury within the last 2 months,
    • Cancer / chemotherapy
  • Other known health condition, should be considered upon disclosure in health assessment form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Spire Medical Health Tag
Spire Medical Health Tag is worn by all subjects The study is open label
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.

Other Names:
  • GE Healthcare S5 Multi-parameter monitoring system
  • End Tidal Carbon Dioxide (EtCO2)
  • 3- lead ECG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measurement of respiratory rate to the Reference
Time Frame: 60 seconds
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spire, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinimark, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dena Raley, BS, CTO Clinimark LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR 2019-330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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