此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation (ONWARD - AV)

2026年6月10日 更新者:Eske Kvanner Aasvang

Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients

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.

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

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Copenhagen、丹麦、2100
        • Rigshospitalet
      • Copenhagen、丹麦、2400
        • Bispebjerg Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Adult, hospitalized patients who are monitored for vital signs in the general wards
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.

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
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.

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.

次要结果测量

结果测量
措施说明
大体时间
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.

Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care

Evaluated by 5-point Likert scale:

  1. Strongly Disagree
  2. Disagree 3- Undecided

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.

其他结果措施

结果测量
措施说明
大体时间
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.
Total alert rate, including false alert rate, of the WARD-CSS.
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
Postoperative complications
大体时间:30 days
Postoperative complications, defined by internationally agreed criteria
30 days
Heart rate (measured in beats per minute (BPM))
大体时间:7 days
Collected continuously
7 days
SpO2 (blood oxygen saturation, measured in percentage)
大体时间:7 days
Collected continuously
7 days
Blood pressure (measured in mmHg)
大体时间:7 days
Collected continuously
7 days
Respiration Rate (measured in BrPM)
大体时间:7 days
Collected continuously
7 days
Pulse (measured in BPM)
大体时间:7 days
Peripheral pulse - Collected continuously
7 days
Temperature (measured in degrees Celcius)
大体时间:7 days
Collected continuously
7 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月28日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2028年3月31日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

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)?

未定

IPD 计划说明

Data access can be discussed upon request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅