跳至主要内容
临床试验/NCT05639452
NCT05639452已完成不适用

Investigator-initiated, Retrospective, Single-center Study for the Development of an Early Warning Score for Detecting the Deterioration of a Patients' General Condition in an Acute Hospital

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
210
试验地点
1
主要终点
Accuracy of Early Warning Score

研究概览

简要总结

An acute deterioration of a patients' general condition is often preceded by changes in individual vital parameters. An early warning system (EWS) shall be developed with a reduced number of physiological and individual parameters, compared to conventional early warning systems; and an algorithm will be generated that is able to predict clinical deterioration. Its predictive power and accuracy shall be investigated. In a second exploratory phase, different model variants will be analyzed and the applicability of the model variants in the context of continuous EWS on wearables will be examined.

详细描述

An acute deterioration of a patients' general condition is often preceded by changes in individual vital parameters and may lead to adverse events, such as admission to the intensive care unit, heart attack or death. Some of them are potentially avoidable if appropriate measures are taken in a timely manner. Therefore early warning systems (Early Warning Scores= EWS) have been developed from a set of several physiological measurements, signs and symptoms. Individual parameters are weighted to sum up a score.

Based on this score, the deterioration of a patients' general condition may be indicated and a predetermined reaction from the professional staff be triggered (so-called track-and-trigger system). It is important to determine all parameters since missing values influence the informative value of an EWS. This requires a higher effort by the staff and is one of the reasons why early warning systems are not yet used systematically in Switzerland.

A reduction in the number of parameters to be measured could lower the hurdle for the use of these tools and enable a broader applicability. Therefore an early warning system shall be developed with a reduced number of physiological and individual parameters, compared to conventional early warning systems; and an algorithm will be generated that is able to predict clinical deterioration. Its predictive power and accuracy shall be investigated, based on various clinical outcomes such as mortality, cardiac arrest, transfer to the intensive care unit or sepsis. Retrospective, encrypted patient data (from 2016 until 2022) will be used to develop a statistical prediction model. In a second exploratory phase, different model variants will be analyzed and the applicability of the model variants in the context of continuous EWS on wearables will be examined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients of surgical and medical wards of University Hospital Basel
  • Hospital stay longer than 24 hours
  • Signed general consent

排除标准

  • Patients admitted directly to the intensive care unit
  • Rejection of general consent

结局指标

主要结局

Accuracy of Early Warning Score

时间窗: up to 72 hours after hospital admission

The accuracy of the early warning system in terms of its predictive power is measured by using the respective medical outcomes. Data models are used to create a relationship between the patient parameters (the predictors) and the clinical outcome (Condition stable vs. condition unstable: death, transfer to intensive care unit, heart attack, infection/sepsis, etc.) as a binary response variable (whether a deterioration occurs or not).

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验