Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, 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 60 post-ICU (Intensive Care Unit) patients and over 7 days.
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 (SpO2), 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 clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy, connectivity, generation of artifactual data and stability of data transmission. The study population includes 60 patients transferred to post-ICU units for a minimum of 5 days. Once in the post-ICU unit, the MultiSense® strip will be attached on patient's thorax. The monitoring will last between 5 to 7 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 years old.
- •Patient previously cared in an ICU for severe COVID-19 pneumonia, COVID-related condition or similar neurological compromise necessitating post-ICU rehabilitation
- •Negative respiratory SARS-CoV-2 (Severe Acute Respiratory Syndrome-Corona Virus-2) samples
- •Patient admitted in a post-ICU rehabilitation unit with an expected length of stay > 5 days
- •Patient able to receive and understand information related to the study and give written informed consent.
- •OR If the patient is not capable, presence of a next of kin able to receive and understand information related to the study and give written informed consent for the patient
- •Patient authorizing the treatment of their personal data collected during the study (box checked in the consent form)
- •Patient affiliated to the French social security system.
排除标准
- •Patient with a skin disease that would preclude the use of an adhesive.
- •Patient with an implantable device such as a pacemaker
- •Pregnant or lactating patient.
- •Patient in exclusion period (determined by a previous or a current study).
- •Patient under guardianship or trusteeship.
- •Patient under the protection of justice.
研究组 & 干预措施
Remote Automated Monitoring System
MultiSense® strip will be attached on patient's thorax. The monitoring will last between 5 and 7 days during the post-ICU hospitalization, at rest and during rehabilitation exercises.
干预措施: Remote Automated Monitoring System (Other)
结局指标
主要结局
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy.
时间窗: from patch placement to hospital discharge, assessed up to 7 days
Accuracy is defined as an average measurement variation less than 3.5 percent or 5 percent of the mean value, depending on the variable with respect to the reference standard.
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of generation of artifactual data.
时间窗: from patch placement to hospital discharge, assessed up to 7 days
The generation of artefact data is defined as a percentage of outlier data less than 10 percent.
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of stability of data transmission.
时间窗: from patch placement to hospital discharge, assessed up to 7 days
Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of connectivity.
时间窗: from patch placement to hospital discharge, assessed up to 7 days
Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.
次要结局
- Usability of a data acquisition patch by health care providers (HCPs) in the setting of post-ICU, rehabilitation unit assessed via a questionnaire.(At hospital discharge, up to 7 days after the patch placement)
- Assess patients' tolerability to prolonged use of an adhesive patch during remote monitoring.(From patch placement to its removal (up to 7 days))
- User experience of post-ICU rehabilitation patients with the continuous use of the adhesive data acquisition patch during remote monitoring assessed via a patient's final questionnaire.(At hospital discharge, up to 7 days after the patch placement)
- Assess the ability of the patch to detect and signal the clinically confirmed excursions of heart rate (high and low) outside predefined thresholds(From patch placement to its removal (up to 7 days))
- Assess the ability of the patch to detect and signal the clinically confirmed excursions of respiratory rate (high and low) outside predefined thresholds(From patch placement to its removal (up to 7 days))
- Assess the correlation between body temperature and skin temperature(From patch placement to its removal (up to 7 days))
- Assess the ability of the patch to detect and signal the clinically confirmed excursions of SpO2 (low) outside predefined thresholds(From patch placement to its removal (up to 7 days))