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NCT04104737 · ClinicalTrials.gov registry record · NA
Spire Medical Health Tag Respiratory Rate Validation in Adults
A NA study of Respiratory Rate, sponsored by Spire.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT04104737 is a NA study of Respiratory Rate that has completed, run by Spire. The registered enrollment target is 20 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT04104737, a NA study of Respiratory Rate, has completed, sponsored by Spire.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- DEVICE Spire Medical Health Tag
Study Locations (2)
California
- Spire, Inc. - San Francisco
Colorado
- Arthur Cabrera, MD. - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-06-04 |
| Est. Completion | 2019-06-13 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04104737
The ClinicalTrials.gov registry entry for NCT04104737 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spire, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Rate appearing as the primary indexed condition, and to 1 intervention - of which Spire Medical Health Tag is the first listed.
NCT04104737 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04104737 about?
NCT04104737 is a clinical study titled "Spire Medical Health Tag Respiratory Rate Validation in Adults". 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...
What is the current status of trial NCT04104737?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2019-06-04. Estimated completion is 2019-06-13.
What conditions does trial NCT04104737 study?
This clinical trial studies the following conditions: Respiratory Rate.
What interventions are being tested in trial NCT04104737?
The interventions under investigation include: Spire Medical Health Tag (DEVICE).
Who is sponsoring clinical trial NCT04104737?
This trial is sponsored by Spire, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04104737 being conducted?
This trial has 2 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.