Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)
研究概览
简要总结
Validate the performance of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in determining functional arterial oxygen saturation (SpO2) using arterial saturation (SaO2) as a reference in the range of 70-100% in subjects of varying skin pigmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •(Eligible Subjects):
- •Subject is 18 to 50 years of age.
- •Subject weighs a minimum of 110 lbs.
- •Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
- •Blood Pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
- •Hemoglobin value ≥ 11 g/dL.
- •CO value ≤ 3.0% FCOHb.
- •Subject can read and communicate in English and understands the study and the risks involved.
排除标准
- •(Ineligible Subjects) (* = per clinician discretion):
- •Subject is pregnant or breastfeeding.
- •Subject has a BMI >
- •Subject has a history of fainting (vasovagal syncope), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
- •Subject has open wounds, inflamed tattoos, or piercings, and/or has any visible healing wounds that a medical professional determines may place them at an increased risk for participation. *
- •Subject has finger deformities, nail deformities, nail polish, and/or gel/acrylic that can interfere with study device placement. *
- •Subject has known drug or alcohol abuse.
- •Subject uses recreational drugs. *
- •Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
- •Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
- •Subject has any history of a stroke, myocardial infarction (heart attack), and/or seizures.
- •Subject has any chronic bleeding disorder (e.g., hemophilia).
- •Subject has taken anticoagulant medication within the past 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDs)).
- •Subject has donated blood within the past 4 weeks.
- •Subject has any cardiac dysrhythmia (e.g., atrial fibrillation) and has not received clearance from their physician to participate.
- •Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. *
- •Subject has taken opioid pain medication 24 hours before the study.
- •Subject has any infectious disease (e.g., Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles). *
- •Subject is taking medications known to treat any type of infectious disease.
- •Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
- •Subject has had invasive surgery within the past year, including but not limited to major dental surgery, appendectomy, plastic surgery, jaw surgery, major ENT surgery, major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery. *
- •Subject has symptoms of congestion, head cold, or other illnesses.
- •Subject has been in a severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
- •Subject has any cancer or history of cancer (not including skin cancer). *
- •Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.
- •Subject is allergic to lidocaine, chlorhexidine, latex, adhesives, or plastic.
- •Subject has a heart condition, insulin-dependent diabetes, uncontrolled hypertension, or hypercholesterolemia.
- •Subject delivered vaginally, had a pregnancy terminated, had a miscarriage with hospitalization, or had a C-section within the past 6 months.
- •Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis), exercise (e.g., working out, riding a bike, riding a skateboard), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
- •Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.
- •Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
研究组 & 干预措施
Test Subject
All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors
干预措施: Philips FAST SpO2 with Masimo Pulse Oximetry Sensors (Device)
结局指标
主要结局
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)
时间窗: 1 hour
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n.
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS)
时间窗: 1 hour
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt CS) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n.
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI)
时间窗: 1 hour
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® YI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n.
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI)
时间窗: 1 hour
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DBI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n.
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx)
时间窗: 1 hour
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (LNCS® Adtx) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n.
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I)
时间窗: 1 hour
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® TC-I) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n.
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI)
时间窗: 1 hour
The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DCI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n.
次要结局
未报告次要终点