Feasibility Evaluation of a Strap-Based Wearable Optical Device (Hemorai Vysio) for Monitoring Hemodynamic Trends and Early Indicators of Blood Loss in Perioperative and Postoperative Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of scheduled Vysio recording windows containing signal data
研究概览
简要总结
The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use during and after inpatient surgery. The device does not provide absolute clinical measurements. Researchers will also explore whether changes recorded by the device occur around signs or treatments related to blood loss.
The main questions are:
- Can the device collect usable information during and after surgery without interfering with routine care?
- What device-related problems, such as skin irritation or discomfort, occur?
- Do changes in the device measurements occur around changes in blood pressure, laboratory results, fluid administration, or blood transfusion?
- How comfortable and practical is the device for participants and bedside nurses?
Participants undergoing surgery will wear the device on the upper arm or chest. Trained study staff will apply it before surgery. It will remain in place for up to 48 hours after surgery, or until discharge or earlier removal. Participants will continue to receive usual hospital monitoring and care.
Bedside nurses may also join the study and complete a short voluntary survey. Nurses may check the device position and adjust the strap for comfort. They will not interpret the device measurements or use them to make treatment decisions.
Hemorai Vysio is an investigational device. Its measurements will be analyzed for research and will not be used to guide participants' medical care. Participants are not expected to receive a direct medical benefit from taking part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgical participants:
- •18 to 85 years of age
- •Undergoing inpatient surgery with an expected overnight hospital stay
- •Capable of providing informed consent
- •No anticipated contraindications to skin-worn sensors
- •Hemodynamically stable at enrollment, with no vasopressor requirement
- •Nursing participants:
- •Bedside nurse caring for an enrolled surgical participant during the Vysio device-wear period
- •Capable of providing informed consent for the study-related usability survey
- •Willing to complete the voluntary usability survey
排除标准
- •Surgical participants:
- •Pregnancy; participants of childbearing potential with a positive pregnancy test before surgery
- •Cognitive impairment or inability to provide informed consent
- •Hemodynamic instability requiring vasopressors at enrollment
- •Severe dermatitis or another skin condition at the planned device application site
- •Known allergy or prior adverse reaction to silicone elastomer, thermoplastic elastomer, or components of the self-adherent elastic wrap (cotton/polyester substrate or synthetic elastic yarn)
- •Active skin breakdown, dermatitis, eczema, burns, or a surgical incision at the planned strap contact site
- •Condition compromising skin integrity such that the site would not qualify as intact skin under ISO 10993-1:2018
- •Nursing participants:
- •Not caring for an enrolled surgical participant during the Vysio device-wear period
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Hemorai Vysio Monitoring
Adult surgical participants will wear the investigational Hemorai Vysio device on the upper arm or chest during surgery and for up to 48 hours after surgery, or until earlier discharge, withdrawal, or clinically indicated removal. The device records research-only optical signals in parallel with standard care. Device data will be analyzed offline and will not be used to guide clinical decisions.
干预措施: Wearable optical hemodynamic monitoring device (Device)
结局指标
主要结局
Percentage of scheduled Vysio recording windows containing signal data
时间窗: From device placement before surgery through device removal, up to approximately 54 hours
For each patient participant, the number of scheduled 2-minute Vysio recording windows containing recorded signal data will be divided by the number of scheduled windows during device wear and multiplied by 100. The percentage will be summarized descriptively across participants as a measure of device-data completeness.
次要结局
未报告次要终点