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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: Completed NA study of Respiratory Rate, sponsored by Spire.
NCT04104737 is a NA study of Respiratory Rate that has completed, run by Spire. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT04104737 record still lists
NCT04104737 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04104737's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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