the accuracy of the dormotech vlab during stable hypoxia plateaus

Conditions: Healthy

Summary: the purpose of the study is to determine the accuracy of the dormotech vlab (spo2) sensor in accordance with the fda guidance on pulse oximeters - premarket notification submissions \[510(k)s\], in range of arterial hbo2 saturations from 100% down to 70%. this was a prospective study with healthy volunteers. the primary objective of the study was to determine the accuracy of the dormotech vlab sensor from saturations from 100 down to 70%. as the primary endpoint, the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief, steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a multi-wavelength hemoximeter).

the purpose of the study is to determine the accuracy of the dormotech vlab (spo2) sensor in accordance with the fda guidance on pulse oximeters - premarket notification submissions \[510(k)s\], in the range of arterial hbo2 saturations from 100% down to 70%. the subjects represent a diverse group in terms of age, height, weight, ethnicity, and skin types, which is beneficial for generalizing findings across different demographics. subjects span all six types, indicating a wide range of skin types from very fair (type i) to deeply pigmented dark (type vi). this was a prospective study with healthy volunteers. the primary objective of the study was to determine the accuracy of the dormotech vlab sensor from saturations from 100 down to 70%. as the primary endpoint, the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief, steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a multi-wavelength hemoximeter).

Eligibility criteria:
inclusion criteria: * subject is male or subject is male or female, aged 18 and \< 50. * subject is in good health with no evidence of any medical problems. * subject is fluent in both written and spoken english. * subject has provided informed consent and is willing to comply with the study procedure exclusion criteria: * subject is obese (bmi \>35). * subject has 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. * subject uses any anticoagulative medication (blood thinner). * subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. * subject has any other serious systemic illness. * subject is a current smoker. * subject with any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly. * subject has a history of fainting or vasovagal response. * subject has a history of sensitivity to local anesthesia * subject has a diagnosis of raynaud's disease * subject has claustrophobia * subject has unacceptable collateral circulation based on exam by the investigator (allen's test). * subject is pregnant, lactating or trying to get pregnant. * subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures. * subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Keywords: forehead reflectance spo2 sensor