Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation (ONWARD - AV)
Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients
研究概览
详细说明
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
The study will focus on adult, hospitalized patients who are monitored at the general hospital ward with continuous, real-time vital sign monitoring combined with the WARD-CSS (WARD clinical support system) that relays alerts to the clinical staff in case of significant deviations. The evaluation focus on the user perceived relevance and usefulness of the alerts generated by the system which includes a proprietary novel alerts logic. Specifically, investigators aim to assess how users evaluate the clinical relevance of triggered change-based alerts and the helpfulness of the accompanying alert descriptions.
During monitoring, the app will be used according to the intended use and additionally two questions will be prompted if alerts are sent.
Patients monitored will have an expected length of stay at the hospital, which supports at least one day of continuous monitoring. Readings from the WARD-CSS is not blinded for treating staff to get feedback on the use of the application. This study will include up to 100 patients.
An alerting feedback questionnaire will be constructed as simple feedback buttons/sliders, prompted after an alert is 'accepted' in the app. The feedback buttons will only be prompted for a representative proportion of the alerts. This will be done at random based on the alert frequencies determined in the retrospective analysis. This way, a close to equal amount of feedback responses will be prompted and obtained for different alert types with different occurrences. The feedback will be linked to the alert in the app, such that feedback can be submitted at any point in time, thus not disturbing the nurse while medical intervention is provided.
The feedback will be constructed with the following two interactions for the clinical staff.
- Alert relevance in relation to deterioration of the patient (5-point Likert scale).
- Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care (5-point Likert scale)
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Eske K Aasvang, DMSci
- 电话号码:+4526232076
- 邮箱:Eske.Kvanner.Aasvang.01@regionh.dk
研究联系人备份
- 姓名:Aslak B Johansen, M.D.
- 电话号码:+4522952551
- 邮箱:aslak.broby.johansen@regionh.dk
学习地点
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Copenhagen、丹麦、2100
- Rigshospitalet
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Copenhagen、丹麦、2400
- Bispebjerg Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion criteria:
Patients can be included if they meet all the following criteria:
- Age ≥ 18 years
- Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration.
- Expected admission for more than 24 hours to a general ward.
Exclusion criteria:
Patients are excluded if they meet any of the following criteria:
- Having implanted electronic devices (such as pacemaker or Implantable Cardioverter Defibrillator (ICD) device).
- Known pregnancy or breastfeeding
- Inability to give informed consent.
- The participant expected not to cooperate with study procedures.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Adult, hospitalized patients who are monitored for vital signs in the general wards
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The intervention involves continuous, real-time vital sign monitoring using sensors to measure vital signs combined with WARD-CSS and novel algorithms designed to detect clinically relevant deviations in the vital signs.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Relevance of alerts
大体时间:Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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The staff evaluated relevance of alerts triggered during continuous vital signs monitoring Evaluated by 5-point Likert scale: 1. Not relevant 2 Slightly relevant 3 Moderately relevant 4 Relevant 5 Highly Relevant |
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Relevance of the description
大体时间:Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care Evaluated by 5-point Likert scale:
4 Agree 5 Strongly Agree |
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Alert rate
大体时间:Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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Total alert rate, including false alert rate, of the WARD-CSS.
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Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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Postoperative complications
大体时间:30 days
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Postoperative complications, defined by internationally agreed criteria
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30 days
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Heart rate (measured in beats per minute (BPM))
大体时间:7 days
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Collected continuously
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7 days
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SpO2 (blood oxygen saturation, measured in percentage)
大体时间:7 days
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Collected continuously
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7 days
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Blood pressure (measured in mmHg)
大体时间:7 days
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Collected continuously
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7 days
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Respiration Rate (measured in BrPM)
大体时间:7 days
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Collected continuously
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7 days
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Pulse (measured in BPM)
大体时间:7 days
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Peripheral pulse - Collected continuously
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7 days
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Temperature (measured in degrees Celcius)
大体时间:7 days
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Collected continuously
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7 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2502107 (MREC)
- 2025071987 (其他标识符:DMA)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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