Postmarket Clinical Follow-up Study (PMCF) to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Accuracy of Heart Rate Measurement at 80-100% SpO2
研究概览
简要总结
This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment in a controlled desaturation study over a range between 80% and 100% peripheral oxygen saturation (SpO2).
The study will be performed on a group of healthy volunteers in a controlled clinical setting.
详细描述
This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment (Nellcor™ Bedside Respiratory Patient Monitoring System model PM1000N, Covidien LLC, USA) in a controlled desaturation study over a range between 80% and 100% SpO2.
The study will be performed on a group of healthy volunteers in a controlled clinical setting. Due to the use of a controlled desaturation protocol foreseen by the standard ISO 80601-2-61:2017, this study is classified as an interventional post-market clinical study in accordance with Annex I of EN ISO 14155:2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Healthy subjects of both sexes with an age ≥ 18 and ≤
- •American Society of Anesthesiology (ASA) classification 1
- •Positive Allen's test
- •Intact and healthy skin on the selected wrist
- •Wrist circumference diameter between 150 mm e 200 mm.
- •Normal electrocardiogram (ECG) obtained at screening or within 2 months prior to screening
- •Ability to understand and execute the required study procedures and provide an informed consent to the study
排除标准
- •Presence of at least one of the following altered hemoglobin parameters at screening:
- •Alpha-hemoglobin (αHb) ≤ 10 gr/dl
- •Carboxy-hemoglobin (COHb) ≥ 3%
- •Methaemoglobin (MetHb) ≥ 2%
- •For pre-menopausal female subjects only: positive pregnancy test performed at screening on urines or capillary blood
- •Presence of any cardiovascular pathology in medical history.
- •Any episodes of respiratory infection during the 30 days prior to screening
- •Any prior experience of Dyspnea
- •Hospitalization during the 2 months prior to screening, for any reason.
- •Chronic drug intake known to interfere with gaseous exchanges or induce changes in cardiac frequency
- •Presence of any medical condition not allowing the subject to perform the required test
- •Known allergy to adhesive tapes
- •Participation in an interventional study with a medicinal product or a medical device in the 30 days prior to screening.
结局指标
主要结局
Accuracy of Heart Rate Measurement at 80-100% SpO2
时间窗: The test started around 2 minutes after beginning of the test session and ended after around 33 minutes.
Accuracy of measurements obtained with BrOxy M with that obtained with the reference pulse oximeter in paired observations. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter.
Accuracy of SpO2 Measurement at 80-100% SpO2
时间窗: The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later.
Accuracy of SpO2 measurements obtained with BrOxy M in comparison with the reference pulse oximeter in paired observations over a range between 80% and 100% SpO2. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter.
次要结局
- Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2(Around 5 min after beginning of the test session)
- Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2(After around 10 min after beginning of the test session)