SpO2 Validation Study - All.Health Algo Oximeter Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- SP02 accuracy
研究概览
简要总结
The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing continuous information to clinicians about patients' oxygenation status. all.health is dedicated to developing and applying innovative electronic medical solutions that improve patient care with the Algo Oximeter Software, to be used in applications for monitoring oxygen saturation.
详细描述
The purpose of this clinical study is to validate the SpO2 accuracy performance of the all.health SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the all.health pulse oximeter.
The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. An investigational device will be placed on the wrist of the side opposite the arterial catheter following the instructions for use. Additional devices may be placed on the back of the wrist with the arterial catheter using a wrist strap. The site(s) where sensors are placed will be measured. Simultaneous data collection will be set up for the device under test and control oximeter.
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
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must have the ability to understand and provide written informed consent.
- •Participant is adult 22-50 years of age.
- •Participant must be willing and able to comply with study procedures and duration.
- •Participant is a non-smoker or who has not smoked within 2 days prior to the study.
- •Male or female of any race.
排除标准
- •Participant has a resting SpO2 < 92% as assessed by a pulse oximeter
- •Participant is considered as being morbidly obese (defined as BMI >39.5)
- •Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path 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.)
- •Females who are pregnant
- •Females who are trying to get pregnant with confirmation of positive urine pregnancy test
- •Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- •Participants with known respiratory conditions such as: (self-reported)
- •uncontrolled / severe asthma,
- •pneumonia / bronchitis,
- •shortness of breath / respiratory distress,
- •unresolved respiratory or lung surgery,
- •emphysema, COPD, lung disease
- •Recent COVID with hospitalization
- •Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
- •high blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings (reviewed during health screen)
- •have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA)
- •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
- •diabetes,
- •uncontrolled thyroid disease,
- •kidney disease / chronic renal impairment,
- •history of seizures (except childhood febrile seizures),
- •epilepsy,
- •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.
- •Participants with known clotting disorders (self-reported)
- •history of bleeding disorders or personal history of prolonged bleeding from injury
- •history of blood clots
- •hemophilia
- •current use of blood thinner: prescription or daily use of aspirin
- •Sickle Cell Trait or Disease
- •Participants with severe contact allergies to standard adhesives, latex, silicone or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- •Participants with severe allergies to iodine (only applicable if iodine is used)
- •Participants with severe allergies to lidocaine (or similar pharmacological agents, e.g.
- •Novocaine),
- •Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio <0.4)
- 另有 3 项未显示
研究组 & 干预措施
all.health wristband
The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The all.health wristband will be placed on the wrist of the side opposite the arterial catheter following the instructions for use. Simultaneous data collection will be set up for the device under test and control oximeter.
干预措施: No intervention (observational study) (Device)
结局指标
主要结局
SP02 accuracy
时间窗: April 2026-May 2026
It is required that the Accuracy Root Mean Square (ARMS) performance of the Sponsor's DUT will meet a specification of 3.0 % or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings.
次要结局
未报告次要终点