Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well Perfused Subjects With the USB Pulse Oximetry Monitor Interface Cable
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- SpO2 Accuracy During Motion Conditions - MaxA Sensor
研究概览
简要总结
To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.
详细描述
Use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Male or female of any race
- •18-50 years old, inclusive
- •Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia)
- •Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening)
- •Meets specific demographic requirements for the monitoring device under study
- •Willing and able to provide written informed consent
- •Able to participate for the duration of the evaluation
排除标准
- •A room-air baseline % modulation < 1.5% on all four fingers on the test hand
- •Under 18 years or over 50 years of age
- •Pregnant and/or lactating women
- •Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg
- •Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute
- •History of seizures (except childhood febrile seizures) or epilepsy
- •History of unexplained syncope
- •Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder
- •Recent history of frequent migraine headaches: average of two or more per month over the last year
- •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.)
- •History of acute altitude sickness at or below moderate elevation (up to 5,000-10,000 feet) defined as three or more of the following symptoms: moderate to severe headache, general malaise, dizziness/lightheadedness, nausea/vomiting, fatigue/weakness, shortness of breath, nosebleed, persistent rapid pulse, or peripheral edema
- •History of significant respiratory disease such as severe asthma or emphysema or sleep apnea
- •Sickle cell disease or trait
- •Clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or study physician as designated.
- •History of stroke, transient ischemic attack or carotid artery disease
- •History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
- •History of chronic renal impairment
- •Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
- •Unwillingness or inability to remove colored nail polish or artificial nails from test digit(s)
- •Unwillingness or inability to give informed consent
- •Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g., Novocain) or heparin
- •Recent arterial cannulation (i.e., less than 30 days prior to study date)
- •Six or more arterial cannulations of each (right & left) radial artery
- •History of clinically significant complications from previous arterial cannulation
- •Current use of blood thinners: prescription or daily aspirin use
- •History of bleeding disorders or personal history of prolonged bleeding from injury.
研究组 & 干预措施
Arterial Line
CO-Oximetry value obtained as a comparator. Obtained during motion conditions.
干预措施: Arterial line (Device)
Motion
The subject has to perform motions during the procedure. This is to verify that device is able to read through motion.
干预措施: Motion (Device)
结局指标
主要结局
SpO2 Accuracy During Motion Conditions - MaxA Sensor
时间窗: up to 6 months
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
SpO2 Accuracy During Motion Conditions - MaxN Sensor
时间窗: up to 6 months
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
次要结局
未报告次要终点