Respiratory Rate Clinical Trial
Official title:
BiOSENCY Bora Band Respiration Rate Development and Validation Study
NCT number | NCT04064645 |
Other study ID # | PR2019-319 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 25, 2019 |
Est. completion date | July 25, 2019 |
Verified date | August 2019 |
Source | Biosency |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the BORA BAND™ Wristband Monitoring System to the Reference. Respiratory Rate will be compared to an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). The testing will be conducted in two phases. The first phase will be an initial data collection to assist in the algorithm development of respiration rate. Upon a successful Phase one performance, the second phase will be the Respiratory Rate Validation conducted at a different period in time.
Status | Completed |
Enrollment | 27 |
Est. completion date | July 25, 2019 |
Est. primary completion date | July 25, 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 - Wrist circumference with the range of 5.5-8 inches (13 to 21cm) Exclusion Criteria: - 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. Tattoo in the optical path 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 | Clinimark Laboratory | Louisville | Colorado |
Lead Sponsor | Collaborator |
---|---|
Biosency | Clinimark, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of BORA Band respiratory rate measurements versus reference end-tidal CO2 | Accuracy of the BORA Band respiratory rate measurement as compared to reference end-tidal CO2. Results shall include: Respiratory rate root mean square accuracy of BORA Band Respiratory rate bias of BORA Band |
5 days |
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