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临床试验/NCT04748289
NCT04748289终止不适用

Integrated Platform for Multimodal Patient Monitoring and Therapy Support in ICU Patients: Interventional Study With First ICU Cockpit Software Applications

Emanuela Keller2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
90
试验地点
2
主要终点
Verification of ICU Cockpit software for remote monitoring of isolated patients

研究概览

简要总结

In neurocritical care, besides the standard intensive care monitoring, even more data are obtained from the very complex pathophysiological changes in brain disease. Medical staff for decision-making cannot integrate the huge amount of clinical data generated every second and visualized on different monitors, anymore. Lack of data integration and usability is a major reason that only few of the knowledge physicians use in this field is evidence based.

Early warning systems, powered by predictive algorithms that detect critical states before they happen would allow the staff to intervene early and mitigate or even prevent such a critical state.

详细描述

Background:

Since 2014, the project "ICU-Cockpit" has been set up at the Neurointensive Unit of the University Hospital Zurich in collaboration with the University of Zurich and ETH Zurich. State-of-the-art information technology collects, synchronizes and encrypts data from numerous medical devices in real time. The project is aimed at initiating a fundamental development in emergency and intensive medicine - and bringing about a substantial improvement in the way diagnostics, treatment and risk management are handled in everyday clinical practice.

Based on video monitoring, algorithms for early alarm systems and therapy support have been already developed. In order to make the algorithms usable for clinical practice, a user interface (GUI) is currently being developed in cooperation with the University of Applied Sciences Northwestern Switzerland (FHNW), see appendix 15. The GUI allows to visualize and interpret the multimodal patient data in a comprehensive manner.

In 2016, a research project started at the NICU of the University Hospital Zurich started with the title "ICU Cockpit: Integrated platform for multimodal patient monitoring and therapy support in neurocritical care" (BASEC No. 2016-01101). The purpose of the single site project is to set up an integrated platform (scientific prototype of ICU Cockpit software platform) for multimodal patient monitoring and therapy support in neurocritical care, and as a second step to develop and validate algorithms for some first clinical applications. Furthermore, automatic artefacts detections (i.e., number of false and true alarms in ICU Cockpit in comparison to standard monitoring system) are assessed and algorithms are developed for the early detection of epileptic seizures and secondary impairment of cerebral perfusion.

The objective of this current clinical investigation is the verification and validation of the ICU Cockpit software platform and the following three different applications for prognostication and prediction of complications:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients admitted to the Neurointensive Care Unit (NICU)
  • Informed Consent by signature from representative / patient

排除标准

  • 未提供

研究组 & 干预措施

NICU patients

Experimental

All patients admitted to the Neurointensive Care Unit (NICU)

干预措施: ICU Cockpit software testing (Device)

结局指标

主要结局

Verification of ICU Cockpit software for remote monitoring of isolated patients

时间窗: 2 years

Repeatability, reliability, performance of prediction of models results will be testet against ground truth (annotations by experts).

Verification of ICU Cockpit software ICU Cockpit Stable State

时间窗: 2 years

Repeatability, reliability, performance of prediction of models results will be testet against ground truth (annotations by experts).

Verification of ICU Cockpit software Cerebral Ischemia

时间窗: 2 years

Prediction score estimated by the app ICU Cockpit Cerebral Ischemia compared to probability estimation by medical experts in surveys.

Usability testing

时间窗: 2 years

Usability testing by distributing the Software Usability Questionnaire to involved medical staff (n=65).

Adverse events, complaints and use-errors reporting

时间窗: 2 years

Reporting of adverse events (incl. device deficiencies), complaints as well as use-errors.

次要结局

未报告次要终点

研究者

发起方
Emanuela Keller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emanuela Keller

Neurocritical Care Unit, University Hospital Zurich

University of Zurich

研究点 (2)

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