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

NCT04748289 | Terminated

• 1 other identifier: 2020-02177
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Decision Support System

Keywords

Secondary brain injuries; COVID-19; Subarachnoid hemorrhage

Outcome Measures

Primary Outcomes (5)

• 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).

  2 years

• 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).

  2 years

• 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.

  2 years

• Adverse events, complaints and use-errors reporting

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

  2 years

• Usability testing

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

  2 years

Study Arms (1)

NICU patients

EXPERIMENTAL

All patients admitted to the Neurointensive Care Unit (NICU)

Device: ICU Cockpit software testing

Interventions

ICU Cockpit software testing DEVICE

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).

NICU patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Emanuela Keller: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, CH-8091, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 32203366 BACKGROUND

• 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.

  PMID: 32105632 BACKGROUND

• 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.

  PMID: 32160451 BACKGROUND

• 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.

  PMID: 21311062 BACKGROUND

MeSH Terms

Conditions

COVID-19; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emanuela Keller, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurocritical Care Unit, University Hospital Zurich

Model Details: Open labelled, single centre clinical investigation, with the new ICU Cockpit Software Platform (medical device).

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 10, 2021
• Study Start: March 1, 2021
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)