Accuracy Assessment of Beddr Oximeter

Completed

Conditions studied: Oximetry

In brief

Accuracy performance of Beddr oximeter

Key facts

Study ID

NCT03710993

Run by

Hancock Medical, Inc.

People needed

15

Starts

2018-07-30

Expected to finish

2018-08-03

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject must have the ability to understand and provide written informed consent
• Adult subjects 18 up to 50 years of age
• Subject must be willing and able to comply with study procedures and duration
• Subject is a non-smoker or who has not smoked within 2 days prior to the study.
• Male or female of any race
• Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

You may not qualify if…

• 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.)
• Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
• Subjects with known respiratory conditions such as:
• uncontrolled / severe asthma,
• flu,
• pneumonia / bronchitis,
• shortness of breath / respiratory distress,
• unresolved respiratory or lung surgery with continued indications of health issues,
• emphysema, COPD, lung disease
• Subjects with known heart or cardiovascular conditions such as:
• Hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings.
• 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

Where it is running

• Clinimark — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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