NCT07234279尚未招募不适用
Feasibility of the Investigational Nellcor™ Investigational Device During Non-Motion and Walking Motion Conditions in Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Accuracy of the investigational device SpO2 as compared to the reference device SpO2
研究概览
简要总结
To examine pulse rate and blood oxygen saturation accuracy of the Nellcor™ Investigational Device during non-motion and walking motion conditions in a diverse patient population through non-invasive means
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants ≥18 years of age, and <75 years of age.
- •Participant is able to participate for the duration of the study
- •Participant is willing to sign an informed consent form (ICF)
- •Participant weighs > 40kg
- •Participants must be a non-smoker or not have smoked within 36 hours prior to the study
排除标准
- •Participant self-reported prior injury or trauma to fingers or hands, which in the opinion of the investigator, may change blood flow or vascular supply and affect the ability to test sensors
- •Physiologic abnormalities that prevent proper application of pulse oximetry sensor
- •Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
- •Individuals of childbearing potential who are self-reported as pregnant, or who are self-reported as trying to get pregnant
- •Morbid obesity (defined as BMI > 39.5)
- •Weight > 136 kg
- •Participants who self-report problems of unsteadiness or imbalance issues and/or who are unable to walk on a treadmill without holding onto the handrails
- •Participant self-reported known heart or cardiovascular conditions such as:
- •Uncontrolled hypertension (Systolic pressure ≥ 140mmHg or Diastolic pressure > 90mmHg on 3 consecutive readings day of screening)
- •Heart arrhythmias other than sinus arrhythmia (Self-reported and/or as identified on ECG day of screening).
- •History of heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure, cardiomyopathy, stroke, transient ischemic attack, or carotid artery disease
- •Participants with self-reported clotting disorders, such as:
- •History of bleeding disorders or personal history of prolonged bleeding from injury
- •History of blood clots
- •Hemophilia
- •Current use of prescription blood thinner
- •Participants with other self-reported, known health conditions, such as:
- •Thyroid disease
- •Kidney disease / chronic renal impairment
- •History of seizures (except childhood febrile seizures), epilepsy, or unexplained syncope
- •Recent history of frequent migraine headaches, as determined medically relevant by the PI
- •History of head injury, as determined medically relevant by the PI
- •Cancer / chemotherapy
- •Sickle cell disease
- •History of hospital admission or a surgical procedure in the 60 days prior to study enrollment (self-reported)
- •Participants with any contraindications to protocol specific repositioning techniques
- •Unwillingness or inability to remove colored nail polish from test digit(s)
- •Participants who have self-reported health conditions beyond what is captured in the prior exclusion criteria, which in the opinion of the Investigator and/or Clinical Staff would classify the participant as medically unsuitable
结局指标
主要结局
Accuracy of the investigational device SpO2 as compared to the reference device SpO2
时间窗: From enrollment to study exit, 1.5 hours
Accuracy of the investigational device pulse rate as compared to the reference device pulse rate.
时间窗: From enrollment to study exit, 1.5 hours
次要结局
- Percentage of the time under evaluation that the NellcorTM Investigational Device provides a SpO2 and PR reading(From enrollment to study exit, 1.5 hours)
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