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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
Sponsor:
Information provided by (Responsible Party):
Emanuela Keller, University of Zurich

Brief 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. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
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)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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:

  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).




Primary Outcome Measures :
  1. 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. 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).

  3. 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.

  4. Adverse events, complaints and use-errors reporting [ Time Frame: 2 years ]
    Reporting of adverse events (incl. device deficiencies), complaints as well as use-errors.

  5. Usability testing [ Time Frame: 2 years ]
    Usability testing by distributing the Software Usability Questionnaire to involved medical staff (n=65).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None


Information from the National Library of Medicine

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


Contacts
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Contact: Emanuela Keller, MD +417442555671 emanuela.keller@usz.ch
Contact: Giselle Golby +41442559891 giselle.golby@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, CH-8091
Contact: Emanuela Keller, Prof MD    +41 44 255 56 71    Emanuela.Keller@usz.ch   
Contact: Giselle Golby    +41442559891    giselle.golby@usz.ch   
Sponsors and Collaborators
Emanuela Keller
Investigators
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Principal Investigator: Emanuela Keller, MD University of Zurich
Publications:
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Responsible Party: Emanuela Keller, Neurocritical Care Unit, University Hospital Zurich, University of Zurich
ClinicalTrials.gov Identifier: NCT04748289    
Other Study ID Numbers: 2020-02177
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emanuela Keller, University of Zurich:
Secondary brain injuries
COVID-19
Subarachnoid hemorrhage