NCT01747473已完成不适用
Controlled Acute Hypoxia Studies Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well-perfused Subjects With the Functional Monitoring PCBA-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- SpO2 Accuracy (percentage of blood oxygen saturation)
研究概览
简要总结
Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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 subjects between the ages of 18 to 50 years (inclusive).
- •Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease
- •All female volunteers must have a negative urine pregnancy test prior to participation.
排除标准
- •A room-air baseline % modulation < 1.5% on all four fingers on the test hand
- •Pregnancy or lactating women
- •History of syncopal episodes
- •Hypertension (defined as a systolic pressure of >145 mmHg or a diastolic pressure >90 mm Hg on three consecutive readings)
- •Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
- •History of seizures (except childhood febrile seizures) or epilepsy
- •Routine use of tranquilizers and/or excessive anxiety
- •History of frequent headaches or migraines
- •History of stroke
- •Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
- •History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (> 1 hour)
- •History of significant respiratory disease, such as severe asthma, emphysema, etc.
- •Sickle cell disease or trait.
- •The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.
- •A clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or designee.
- •Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
- •Prior or known allergies to heparin
- •History of transient ischemic attacks or carotid artery disease
- •History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
- •History of chronic renal impairment
- •History of recent arterial cannulation (less than 1 month prior to study)
- •History of complications from previous arterial cannulation
- •Current use of blood thinners
结局指标
主要结局
SpO2 Accuracy (percentage of blood oxygen saturation)
时间窗: Duration of subject visit- approx. 1.5 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During MotionHealthyHypoxiaNCT02247765Medtronic - MITG18
已完成
不适用
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)HealthyNCT01747460Medtronic - MITG25
已完成
不适用
Pulse Oximetry- Performance During Severe Signal InterferenceHealthy SubjectsNCT01720355Medtronic - MITG17
招募中
不适用
Accuracy of Pulse Oximeters During Profound HypoxiaHypoxiaNCT05790616Philips Clinical & Medical Affairs Global66
已完成
不适用
Pulse Oximeter and Respiratory Rate TestHypoxiaHypocapniaHypercapniaNCT03797300Spry Health12