ACTRN12621000028808尚未招募未知
Clinical Validation of a Smart Wearable Device to Monitor Cardiac and Respiratory Vital Signs using Morphic Band Sensors in healthy volunteers and ICU patients on ventilation.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1.Healthy Volunteers must have given written informed consent before any study related activities are carried out and must be able to understand the full nature and purpose of the trial including possible risks. Ventilated participants will not be consented however patient’s Person Responsible will be informed of the study and asked to provide consent.
- •2.Female participants of childbearing potential must not be pregnant or nursing at the time of enrolment.
- •3.Must be able to be fitted with the device.
- •4.Provision of use of a Smart phone for the duration of the study, and willingness to download the App for at-home study.
- •5. If a Healthy participants who consent to the at-home study must be willing to use personal WIFI for App use and phone which has Bluetooth.
- •6.If in ICU arm admitted for ventilatory support using invasive ventilation as part of standard of care.
排除标准
- •1.Known skin sensitivities or allergies to elasticated products.
- •2.Broken skin or rashes on torso (where devices will be in contact with the skin).
- •3.Participant who, in the opinion of the investigator, is not a good candidate for the study.
- •4.Cardiac pacemaker or implantable defibrillator, known to require defibrillation.
- •5.Any medical intervention that would interfere with the study.
- •6.Participant with surgical wounds/dressing precluding the appropriate placement of the investigational device.
研究者
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