The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Measurement of arterial HbO2 saturations from 100% down to 70%
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or Subject is male or female, aged 18 and <
- •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
排除标准
- •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.
结局指标
主要结局
Measurement of arterial HbO2 saturations from 100% down to 70%
时间窗: 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%.
次要结局
未报告次要终点