Verification of Nellcor™ Pulse Oximetry Device With the Nellcor™ Abbreviated Pulse Oximetry Sensor Line in Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Evaluation of pulse rate accuracy
研究概览
简要总结
To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.
详细描述
The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to verify Pulse Rate and SpO2 accuracy in a diverse participant population over a specified saturation range.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 51 Years（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 < 51 years of age.
- •Participant is willing and able to comply with study procedures and duration.
- •Participant is willing to sign an ICF.
- •Participant weighs > 40kg (88.2 lb).
- •Participant is a non-smoker or has not smoked within 36 hours prior to the study.
- •Cleared same day health assessment form and health screening
- •Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow.
排除标准
- •Participant is considered as being morbidly obese (defined as BMI >39.5).
- •Compromised circulation, injury, or physical malformation of fingers, 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 participants to participate if the condition is noted and would not affect the sites utilized)
- •Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study.
- •Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
- •tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
- •MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
- •Participants with known respiratory conditions such as:
- •uncontrolled / severe asthma
- •flu or influenza type infection
- •pneumonia / bronchitis
- •shortness of breath / respiratory distress
- •unresolved respiratory or lung surgery
- •emphysema, COPD, lung disease
- •recent COVID (last 2 months)
- •Participants with known heart or cardiovascular conditions such as:
- •Uncontrolled hypertension (systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings day of screening)
- •previous cardiovascular surgery
- •chest pain (angina)
- •heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- •previous heart attack
- •blocked artery
- •unexplained shortness of breath
- •congestive heart failure (CHF)
- •history of stroke and/or transient ischemic attack
- •carotid artery disease
- •myocardial ischemia
- •myocardial infarction
- •cardiomyopathy
- •implantable active medical device such as pacemaker or automatic defibrillator
- •Self-reported health conditions as identified in the Health Assessment Form:
- •uncontrolled thyroid disease
- •kidney disease / chronic renal impairment
- •history of seizures (except childhood febrile seizures)
- •history of unexplained syncope
- •recent history of frequent migraine headaches (within the last 2 months)
- •recent symptomatic head injury (within the last 2 months)
- •cancer requiring chemotherapy, radiation, or current treatment
- •participants with known clotting disorders
- •history of bleeding disorders or personal history of prolonged bleeding from injury
- •history of blood clots
- •sickle cell trait or disease
- •current use of blood thinner: prescription or daily use of aspirin
- •participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
- •participants with severe allergy to iodine (only applicable if iodine is used)
- •participants with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
- •arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
- •history of clinically significant complications from previous arterial cannulation
- •unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
- •other known health condition, upon disclosure in Health Assessment form
- •Failure of the Allen's Test.
研究组 & 干预措施
Healthy Volunteers
All subjects who meet the inclusion criteria and none of the exclusion criteria will be enrolled into the test group and will participate in data collection with use of the Nellcor™ Pulse Oximetry device with each of the market-released Nellcor™ Pulse Oximetry test sensors.
结局指标
主要结局
Evaluation of pulse rate accuracy
时间窗: 2 - 3 hours
Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the pulse rate measurement from the Nellcor Pulse Oximetry device to the heart rate measurements as obtained by ECG.
Evaluation of saturation accuracy
时间窗: 2-3 Months
Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample.
次要结局
未报告次要终点