Accuracy of Pulse Oximeters With Profound Hypoxia

Completed

Conditions studied: Oximetry

In brief

This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.

Key facts

Study ID

NCT03710980

Run by

Hancock Medical, Inc.

People needed

12

Starts

2018-09-18

Expected to finish

2018-09-19

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…

• The subject is male or female, aged ≥18 and <50.
• The subject is in good general health with no evidence of any medical problems.
• The subject is fluent in both written and spoken English.
• The subject has provided informed consent and is willing to comply with the study procedures.

You may not qualify if…

• The subject is obese (BMI>30).
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• Subject has diabetes.
• Subject has a clotting disorder.
• The subject a hemoglobinopathy or history of anemia, per subject report or the first bloodsample, that in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• The subject is a current smoker.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity to local anesthesia.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• The subject is pregnant, lactating or trying to get pregnant.
• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
• The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Where it is running

• UCSF Hypoxia Lab — San Francisco, California, United States

Full record on ClinicalTrials.gov

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