Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.
研究概览
简要总结
In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 30 healthy volunteers under induced and controlled hypoxia.
详细描述
The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: ECG trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.
The aim of this study is to determine the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System under induced hypoxia, in terms of accuracy.
The study population includes 30 healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Men or women between 18 to 50 years of age.
- •Subject able to receive and understand information related to the study and give written informed consent.
- •Subject is a non-smoker or an ex-smoker (stopped smoking for at least 6 months).
- •Subject demographics include a range of dark skin pigmentations, including at least 30% of the total pool, assessed by phototypes V and VI according to the Fitzpatrick scale (Questionnaire score between 28 and 40).
- •Subject is healthy (assessed by a physical examination AND normal ECG AND absence of medical treatment except for the birth control pill).
- •Subject authorizing the treatment of their personal data collected during the study (box checked in the consent form).
- •Subject affiliated to the French social security system.
排除标准
- •Subject with antecedent of allergies to adhesives or silicone or a skin disease that would preclude the use of an adhesive.
- •Subject with an implantable device such as a pacemaker.
- •Pregnant or lactating women (assessed by a negative ß-HCG test).
- •Subject with a high-altitude stay during the previous 4 weeks (more than 1 week spent over 3,500 meters).
- •Subject with Raynaud's syndrome.
- •Subject in exclusion period (determined by a previous or a current study).
- •Subject under guardianship or trusteeship.
- •Subject under the protection of justice.
研究组 & 干预措施
Remote Automated Monitoring System
Two MultiSense® patches will be placed on each volunteer. The monitoring will last no more than 3 hours, during an induced and controlled hypoxia.
干预措施: Remote Automated Monitoring System (Other)
结局指标
主要结局
Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.
时间窗: from patch placement to patch removal, assessed up to 3 hours
Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. The data for analysis will be equally distributed across the SpO2 range of 70-100%.
次要结局
- Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions(from patch placement to patch removal, assessed up to 3 hours)
- To evaluate the reliability of the respiration rate determined by the MultiSense® solution(from patch placement to patch removal, assessed up to 3 hours)
- Comparison of Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions.(from patch placement to patch removal, assessed up to 3 hours)
- To evaluate the impact of skin pigmentation on SpO2 determination by the MultiSense® solution.(from patch placement to patch removal, assessed up to 3 hours)
- To compare the quality of MultiSense® data from a patch worn on the chest and from a patch worn on the upper back in different body posture and to evaluate the impact of strip exact localization on the chest.(from patch placement to patch removal, assessed up to 3 hours)
- To evaluate pulse transit time (PTT) as an indicator of blood pressure (BP) variation.(from patch placement to patch removal, assessed up to 3 hours)