AzTrials
AzTrials

Clinical Decision Support SystemICUCockpiAppNCT04748289

ICU Cockpit Apps: Interventional Study With First ICU Cockpit Software Applications

A study testing ICU Cockpit software testing in people with Clinical Decision Support System, run by Emanuela Keller at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Clinical Decision Support System
What is being tested?
ICU Cockpit software testing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSwitzerland
Study dates
1 Mar 2021to 9 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Zurich

    Zurich, Canton of Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: 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.

Read the 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:

  1. 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).
  2. 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.
  3. 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.
  4. 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.
Being tested
ICU Cockpit software testing
Keywords
Secondary brain injuries, COVID-19, Subarachnoid hemorrhage
Medical subject headings
COVID-19, Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICU Cockpit software testingDevice

    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:

    1. ICU Cockpit COVID-19 for remote monitoring of isolated patients,
    2. ICU Cockpit Stable State for a comprehensive visualization of vital parameters and as additional aid in early detection of imminent critical complications
    3. ICU Cockpit Cerebral Ischemia for the prediction of delayed DCI in patients with subarachnoid hemorrhage (SAH).
Study groups in NCT04748289
Study groupRoleWhat they receive
NICU patientsExperimentalAll patients admitted to the Neurointensive Care Unit (NICU)
Receives: Device: ICU Cockpit software testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Verification of ICU Cockpit software for remote monitoring of isolated patients

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

    Measured: 2 years

  2. Verification of ICU Cockpit software ICU Cockpit Stable State

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

    Measured: 2 years

  3. Verification of ICU Cockpit software Cerebral Ischemia

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

    Measured: 2 years

  4. Adverse events, complaints and use-errors reporting

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

    Measured: 2 years

  5. Usability testing

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start1 Mar 2021
  3. Primary completion9 Apr 2026
  4. Study completion9 Apr 2026

Why it stopped: new follow-up study will start in 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Open labelled, single centre clinical investigation, with the new ICU Cockpit Software Platform (medical device).
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04748289
Sponsor's protocol ID
2020-02177
Acronym
ICUCockpiApp
Status last verified
Apr 2026
First submitted
27 Jan 2021
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32203366
  • 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.

    PubMed 32105632
  • 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.

    PubMed 32160451
  • 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.

    PubMed 21311062

Questions about this trial

What is this clinical trial studying?

A study testing ICU Cockpit software testing in people with Clinical Decision Support System, run by Emanuela Keller at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: new follow-up study will start in 2026). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Verification of ICU Cockpit software for remote monitoring of isolated patients (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04748289, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in