Respiratory Rate Clinical Trial
Official title:
Spire Medical Health Tag Respiratory Rate Validation in Adults
NCT number | NCT04104737 |
Other study ID # | PR 2019-330 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2019 |
Est. completion date | June 13, 2019 |
Verified date | September 2019 |
Source | Spire, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 13, 2019 |
Est. primary completion date | June 13, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Arthur Cabrera, MD. | Louisville | Colorado |
United States | Spire, Inc. | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Spire, Inc. | Clinimark, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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