NCT05083351已完成不适用
Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- SpO2 Accuracy of the MightySat Pulse Oximeter
研究概览
简要总结
Evaluation of the noninvasive oxygen saturation (SpO2) performance of the noninvasive Masimo MightySat against reference arterial blood samples analyzed by a laboratory CO-oximeter reference instrument. The study will include different subgroups to assess the performance across different genders and 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
- •Subject is 18 to 50 years of age.
- •Subject weighs a minimum of 110 lbs.
- •Subject has a hemoglobin value ≥ 11 g/dL.
- •Subject's baseline heart rate is ≥ 45 bpm and ≤ 85 bpm.
- •Subject's CO value is ≤ 2.0% FCOHb.
- •Subject's 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.
- •Subject is able to read and communicate in English and understands the study and the risks involved.
排除标准
- •Subject is pregnant.
- •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 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 Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
- •Subject has any symptomatic 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 active signs and/or symptoms of infectious disease (e.g. hepatitis, HIV, tuberculosis, flu, malaria, measles, etc.).*
- •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, or uncontrolled hypertension.
- •Subject has delivered vaginally, has had a pregnancy terminated, 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 (working out, riding a bike, riding a skateboard, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
- •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
MightySat
Experimental
All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).
干预措施: MightySat (Device)
结局指标
主要结局
SpO2 Accuracy of the MightySat Pulse Oximeter
时间窗: 1-5 hours
The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.
次要结局
未报告次要终点
研究者
研究点 (2)
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