Integrated Platform for Multimodal Patient Monitoring and Therapy Support in ICU Patients (ICUCockpitAp)
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|ClinicalTrials.gov Identifier: NCT04748289|
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : April 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Clinical Decision Support System||Device: ICU Cockpit software testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open labelled, single centre clinical investigation, with the new ICU Cockpit Software Platform (medical device).|
|Masking:||None (Open Label)|
|Official Title:||Integrated Platform for Multimodal Patient Monitoring and Therapy Support in ICU Patients: Interventional Study With First ICU Cockpit Software Applications|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2023|
Experimental: NICU patients
All patients admitted to the Neurointensive Care Unit (NICU)
Device: ICU Cockpit software testing
the ICU Cockpit Software Platform is intended to be used for monitoring of patient characteristics and vital physiological parameters in patients at the Neurointensive Care Unit of the University Hospital Zurich.
Furthermore, three different applications for prognostication and prediction of complications will be tested:
- Verification of ICU Cockpit software for remote monitoring of isolated patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 years ]Prediction score estimated by the app ICU Cockpit Cerebral Ischemia compared to probability estimation by medical experts in surveys.
- Adverse events, complaints and use-errors reporting [ Time Frame: 2 years ]Reporting of adverse events (incl. device deficiencies), complaints as well as use-errors.
- Usability testing [ Time Frame: 2 years ]Usability testing by distributing the Software Usability Questionnaire to involved medical staff (n=65).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748289
|Contact: Emanuela Keller, MDemail@example.com|
|Contact: Giselle Golbyfirstname.lastname@example.org|
|Principal Investigator:||Emanuela Keller, MD||University of Zurich|