The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
- Conditions
- Healthy
- Registration Number
- NCT06516809
- Lead Sponsor
- Dormotech Medical
- Brief 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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of arterial HbO2 saturations from 100% down to 70% day 1 At the start of each testing cycle, one blood sample was taken while breathing room air.
Subjects then breathed through a partial rebreathing circuit with a nose clip, a mixture of nitrogen, air and carbon dioxide to reach six different stable levels (plateaus) of oxyhemoglobin saturation between 70-100%.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vital Signs Research Group
🇺🇸San Francisco, California, United States
Vital Signs Research Group🇺🇸San Francisco, California, United States