Status:
COMPLETED
Spire Medical Health Tag Respiratory Rate Validation in Adults
Lead Sponsor:
Spire, Inc.
Collaborating Sponsors:
Clinimark, LLC
Conditions:
Respiratory Rate
Eligibility:
All Genders
18+ years
Phase:
NA
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 D...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04104737
Start Date
June 4 2019
End Date
June 13 2019
Last Update
October 30 2019
Active Locations (2)
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1
Spire, Inc.
San Francisco, California, United States, 94110
2
Arthur Cabrera, MD.
Louisville, Colorado, United States, 80027