Verification of Investigational Pulse Oximetry Devices With the Abbreviated Sensor Line in Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Verification of Saturation Accuracy
研究概览
简要总结
The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.
详细描述
To verify the SpO2 and pulse rate accuracy in comparison to reference-standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 18 to 50 years of age
- •Subject is willing and able to comply with study procedures and duration
- •Subject is willing to sign an informed consent
- •Subject weighs >40kg
- •Subject is a non-smoker or has not smoked within 2 days prior to the study
- •Cleared same day health assessment form and health screening
- •Successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.
排除标准
- •Subject 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 subjects to participate if the condition is noted and would not affect the sites utilized)
- •Females 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
- •Subjects 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)
- •Subjects with known heart or cardiovascular conditions such as:
- •hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings
- •have had 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
- •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
- •recent symptomatic head injury, within the last 2 months
- •cancer requiring chemotherapy, radiation, or current treatment
- •subjects 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
- •subjects 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)
- •subjects 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
研究组 & 干预措施
Healthy Volunteers
Observational Study
结局指标
主要结局
Verification of Saturation Accuracy
时间窗: 2.5 hours
Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for the investigational Pulse Oximetry PCBA system, SpO2 across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2% (ARMS) FlexMax ±2.5%(ARMS) DS-100A ±3% (ARMS) D-YS ±3% (ARMS)
Verification of Pulse Rate
时间窗: 2.5 hours
Pulse rate in a diverse subject population over a specified saturation range. The acceptance criteria for pulse rate from 20-250 BPM over a specified saturation range of 70-100%: Pulse Rate Max-A ≤3% BPM (ARMS) OxySoft-N ≤3% BPM (ARMS) Max-Fast ≤3% BPM (ARMS) FlexMax ≤3% BPM (ARMS) DS-100A ≤3% BPM (ARMS) D-YS ≤3% BPM (ARMS)
Proposed claim verification for pulse rate and saturation accuracy
时间窗: 2.5 hours
Acceptance criteria for * SpO2 across the saturation range of 70-100% * Pulse rate from 20-250 BPM
次要结局
未报告次要终点