- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04748289
ICU Cockpit Apps: Interventional Study With First ICU Cockpit Software Applications (ICUCockpitApp)
Integrated Platform for Multimodal Patient Monitoring and Therapy Support in ICU Patients: Interventional Study With First ICU Cockpit Software Applications
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
a) ICU Cockpit COVID-19 for remote monitoring of isolated patients, b) ICU Cockpit Stable State for a comprehensive visualization of vital parameters and as additional aid in early detection of imminent critical complications c) ICU Cockpit Cerebral Ischemia for the prediction of delayed cerebral ischemia in patients with subarachnoid hemorrhage (SAH).
ICU Cockpit COVID-19 for remote monitoring of isolated patients Having infected more than 100 000 people in 100 countries, the coronavirus disease 2019 (COVID-19) has become a pandemic. In China, up to 10% of patients with COVID-19 became severely ill requiring intensive care treatment mostly due to pneumonia, acute respiratory distress syndrome (ARDS) and multiorgan failure. In Italy, having about 5200 beds in intensive care units (ICUs), already 1028 were already devoted to patients with COVID-19 by March 11. Furthermore, 20% of health-care professionals, at this time, have become already infected, and some have died. For the United States, without self-isolation and for R0 = 2 and R0 = 2.5, respectively, ICU admissions are projected to become 17.4 to 25.7 per 1,000 population, which would significantly exceed the capacity of the existing 100,000 ICU beds in the US. Also, in Switzerland the health care system and especially ICUs are facing extraordinary challenges as human resources for ICU professionals are limited.
Advances in medical informatics have the potential to facilitate medical care and save personnel resources not only in the ambulatory sector but in the ICUs especially during epidemics. In intensive and emergency medicine, the situation is compounded by real-time signals from multiple sensors on, as well as inside the human body. In an emergency situation, in particular, it is not possible to integrate this flood of information rapidly into the decision-making process.
Remote monitoring of strictly isolated patients especially reduces routes and walking of the staff, the number of close contacts with infected patients and therefore, virus transmission. The safety of patients will be increased by a reduction of stress and burnouts in nurses and medical doctors, which often work in crisis over time.
ICU Cockpit Stable State As a first application a software called "stable state" has been developed recently. Vital parameters as arterial blood pressure, intracranial pressure and many others are hard to read in a glance due to their high information density. Since the human body is a complexly inter-connected system, these biosignals are also heavily correlated. Experienced clinicians can recognize deviations in the correlational structure of several signals, but it is impossible to grasp the full picture for the huge amount of available data. However, subtle correlational changes may indicate an instable state of a patient before these changes are visible in a specific signal or its compound measure.
An algorithm which computes the inter-dependencies in an arbitrary set of signals during a stable phase of the patient was recently developed. This stable state is compared to an on-line estimate of the current state. Correlational changes are didactically reduced and visualized in a Mondrian-like display for quick comparisons of current and past states.
The application "stable state" as part of the GUI ICU Cockpit is planned to be implemented as an additional aid in early detection of imminent critical complications.
- ICU Cockpit Cerebral Ischemia Cerebral vasospasm (CVS) is a delayed morphologic narrowing of cerebral arteries, occurring 4 to 10 days after aneurysmal subarachnoid hemorrhage. Classically, CVS has been associated with delayed cerebral ischemia (DCI), which ultimately leads to cerebral infarction associated with morbidity and mortality. This has been sort of a paradigm, and the term CVS has been often misused to describe clinical signs of DCI. The majority of research was focused on the assumption CVS to be solely responsible for DCI. Today, it is well accepted that not all patients with CVS develop DCI. Inversely, DCI can occur in the absence of CVS. Recent review of the literature indicates that CVS is not the only cause of DCI and that the entire picture of DCI is multifactorial. There is an ongoing debate about this issue, however cerebral infarction on imaging studies might be the most appropriate measure of DCI beside functional outcome. Therefore, an algorithm to predict DCI based on a random forest model has been developed, which allows to identify biomarkers for the occurrence 24h to 48 hours before.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, CH-8091
- University Hospital Zurich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients admitted to the Neurointensive Care Unit (NICU)
- Informed Consent by signature from representative / patient
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NICU patients
All patients admitted to the Neurointensive Care Unit (NICU)
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2 years
|
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).
|
2 years
|
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.
|
2 years
|
Adverse events, complaints and use-errors reporting
Time Frame: 2 years
|
Reporting of adverse events (incl.
device deficiencies), complaints as well as use-errors.
|
2 years
|
Usability testing
Time Frame: 2 years
|
Usability testing by distributing the Software Usability Questionnaire to involved medical staff (n=65).
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emanuela Keller, MD, University of Zurich
Publications and helpful links
General Publications
- Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.
- Hollander JE, Carr BG. Virtually Perfect? Telemedicine for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1679-1681. doi: 10.1056/NEJMp2003539. Epub 2020 Mar 11. No abstract available.
- Callaway E, Cyranoski D, Mallapaty S, Stoye E, Tollefson J. The coronavirus pandemic in five powerful charts. Nature. 2020 Mar;579(7800):482-483. doi: 10.1038/d41586-020-00758-2. No abstract available.
- Vergouwen MD, Ilodigwe D, Macdonald RL. Cerebral infarction after subarachnoid hemorrhage contributes to poor outcome by vasospasm-dependent and -independent effects. Stroke. 2011 Apr;42(4):924-9. doi: 10.1161/STROKEAHA.110.597914. Epub 2011 Feb 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-02177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clinical Decision Support System
-
Iaso Maternity Hospital, Athens, GreeceCompleted
-
Kaohsiung Medical University Chung-Ho Memorial...RecruitingClinical Decision Support SystemTaiwan
-
University Hospital AugsburgErasmus Medical Center; University Hospital Schleswig-Holstein; Johannes Gutenberg...Not yet recruitingClinical Decision Support Systems
-
Tampere UniversityFinnish Institute for Health and Welfare; The Finnish Funding Agency for Technology... and other collaboratorsCompletedDecision Support Systems, ClinicalFinland
-
University of Colorado, DenverCompletedPalliative Care | Decision Support Systems, Clinical | Decision Making | Decision Support Techniques | HospicesUnited States
-
Escola Superior de Enfermagem de CoimbraInstituto Politécnico de LeiriaNot yet recruitingClinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients (mHEART4U)Decision Support Systems, Clinical
-
University of Illinois at ChicagoAgency for Healthcare Research and Quality (AHRQ); Loyola UniversityCompletedDecision Support Systems, Clinical | Medical Errors | Diagnostic ErrorsUnited States
-
Brigham and Women's HospitalUnknownClinical Decision Support Systems | Ambulatory Care Information SystemsUnited States
-
University GhentResearch Foundation FlandersCompletedArtificial Intelligence | Decision Support Systems, Clinical | Qualitative ResearchBelgium
-
Wuerzburg University HospitalCharite University, Berlin, Germany; Goethe University; RWTH Aachen University; Technical University of Munich and other collaboratorsRecruitingSurgery | ASA Class III/IV Patients | Clinical Decision Support SystemsGermany
Clinical Trials on ICU Cockpit software testing
-
Bien-Willner Physicians Group PANo One Left Alone; Carolina Blood and Cancer Care AssociatesNot yet recruitingAdvanced Cancer | Myeloid Malignancy | Solid Tumor, AdultUnited States
-
Genelex CorporationCompletedDrug Metabolism, Poor, CYP2D6-RELATED | Drug Metabolism, Poor, CYP2C19-RELATED | Cytochrome P450 CYP2D6 Enzyme Deficiency | Cytochrome P450 CYP2C9 Enzyme Deficiency | Cytochrome P450 CYP2C19 Enzyme Deficiency | Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant | CYP2D6 Polymorphism | Ultrarapid... and other conditionsUnited States
-
Neuroganics LLCNeuroganics Diagnostics LLC; Artron Laboratories Inc; AllBio Science Inc.; TurklabRecruitingCOVID-19 | Infectious Disease | Coronavirus | Sars-CoV2 | Communicable Disease | VirusUnited States
-
Washington University School of MedicineMallinckrodtCompletedHealthy Volunteers | Mobile Applications | Feasibility StudyUnited States