ABLY LYNG Study at Helse More Romsdal - Aalesund Sykehus HMR With the Ably LYNG Patient Care Solution Advanced Prototype by Ably Medical AS.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Absolute Relative Error of Heart Rate (beats per minute)
研究概览
简要总结
The study main objective will be to compare measurements of heart rate, respiration rate, blood pressure and movement done by LYNG by Ably Medical with the corresponding measurements made by standard equipment in a patient sample in a hospital setting. The comparison will show the degree of agreement between LYNG and the existing current standard equipment. Data from the study will support Ably Medical in optimizing the LYNG product and measurement precision.
详细描述
The LYNG sensor mat is placed beneath a regular bed matrass and captures data without direct patient contact. Data collected by the LYNG sensor is transmitted via cables to the bed-side connectivity box for initial local analysis and storage. Data will be extracted and formatted for post-analysis in additional software for verification and validation purposes.
Specifically, the LYNG study objectives are as follows:
- collect sensor data from LYNG Solution to optimize the LYNG data algorithms to further improve parameter estimations of patient heart rate, respiratory rate, blood pressure and movement indicators.
- Compare parameter estimation by LYNG against current and relevant standard of care measurement methods
The study design is a within-subjects comparison in parameter estimation with Ably LYNG as comparator to standard of care. Patients will take part in 60-minute sessions where measurements are collected in accidence to standard procedure for the standard equipment while the LYNG system collects the same data non- intrusively. The data will not be part of any clinical decision making or have any impact of the patient care. The study will take place during Q2-Q3/2021 with estimated 8-12 weeks duration including logistics, setup, data collection, study closure.
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
- •For patients:
- •Admitted to hospital,
- •Able to provide voluntary, informed consent.
排除标准
- •For patients:
- •Health condition that endangers patient by participation due to pain, rehabilitation, and/or negative impact on treatment or care, as evaluated by medical personnel,
- •Pregnancy,
- •Significantly reduced mobility that implies substantial strain for moving in and out of bed, as evaluated by medical personnel
- •Unable to provide informed, voluntary consent personally or by legal guardian, * below 18 years old,
- •Patients with implantable devices such as pacemakers, baclofen pumps, insulin pumps, etc, or
- •Any way identified as 'vulnerable'
- •The nurse handing recruitment will explicitly check for inclusion/exclusion criteria alignment and document this in the study Enrolment Form. The routine will be to check for formal criteria and to describe the study in such a manner that the patient understands content, and make sure the patient understands before consenting
结局指标
主要结局
Absolute Relative Error of Heart Rate (beats per minute)
时间窗: 60 minutes
absolute relative error = (reference measure/LYNG measure)/Reference
Absolute Relative Error of Respiration Rate (respirations per minute)
时间窗: 60 minutes
absolute relative error = (reference measure/LYNG measure)/Reference
Movement
时间窗: 60 minutes
Comparison of movement as part of patient instruction compared to indications of movement in movement sensors. Qualitative analysis.
absolute relative error of Blood Pressure = (reference measure/LYNG measure)/Reference
时间窗: 60 minutes
absolute relative error = (reference measure/LYNG measure)/Reference Sphygmomanometer, millimeters of mercury (mmHg) upper (systolic), lower (diastolic), and mean value.
次要结局
未报告次要终点