SpO2 Accuracy Validation of the OxySoftN Sensor Via Reference CO-Oximetry in Healthy, Well-Perfused Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To investigate performance of the OxySoft device by measuring oxygen saturation accuracy over a Low Saturation range of 60-80%
研究概览
简要总结
To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
详细描述
The study utilizes a single-site, physiology laboratory (Clinimark) for non-randomized, prospective, observational studies. The goal is to enroll a minimum of ten subjects. Subjects may be of any race, ranging in pigmentation from light to dark to meet the study design requirements.
The general purpose of Invasive Controlled Desaturation Studies is to validate the SpO2 and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during low saturation conditions. This is achieved through paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of 60 % to 100 % SaO22 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. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison.
Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate. In the unlikely event that the ECG monitor malfunctions, the Pulse rate reference may be taken using the average pulse rate value from the transfer standard pulse oximeters. This study is designed to support an FDA submission for pulse rate and saturation accuracy in a diverse subject population during low saturation conditions over a specified saturation range for the OxySoftN pulse oximetry system.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subject must have the ability to understand and provide written informed consent
- •Adult subjects 18 to 50 years of age.
- •Subject must be willing and able to comply with study procedures and duration.
- •Subject is a non-smoker or who has not smoked within 2 days prior to the study.
- •Male or female of any race.
- •Cleared same day Health Assessment form and health screening.
- •Cleared physical exam by a licensed physician, physician assistant, or advanced practice nurse (medical exam includes 12-lead ECG, medical history and blood test to show no sickle cell disease present)
- •Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral blood flow.
- •Exclusion Criteria
- •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
- •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
- •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
- •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
- •Subjects with known clotting disorders
- •history of bleeding disorders or personal history of prolonged bleeding from injury
- •history of blood clots
- •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
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
To investigate performance of the OxySoft device by measuring oxygen saturation accuracy over a Low Saturation range of 60-80%
时间窗: April 2021
To validate the proposed claims for saturation accuracy in a diverse subject population during Low Saturation over a specified saturation range. The acceptance criteria for the OxySoftN Sensor SpO2 during Low Saturation conditions across the saturation range of 60-80% when paired with the N-600x, PM1000N and Oxicable: SpO2 OxySoftN ± 3% (Arms)
次要结局
未报告次要终点