ICU Background Early Awareness for Critical deterioratiON

NCT07119411 | Not Yet Recruiting

• 1 other identifier: BASEC 2025-00623
• Study Type: observational
• Target: 1,962
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare ICU sub-units, those with additional support of a clinician awareness system, ICU Beacon, and those receiving the standard of care. The win-ratio composite outcome will be assessed by comparing patients by study group and stratified by APACHE score at admission.

Conditions

Respiratory Failure; Circulatory Failure; Mortality; Organ Dysfunction; Organ Failure, Multiple

Keywords

icu; respiratory failure; circulatory failure; early warning system; prevention; prediction; risk prediction; organ failure; multi-organ failure; win-ratio; ICU Beacon

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine whether BEACON improves ICU sub-unit performance, i.e. reduces total mortality and/or mitigates severity of organ failures in an adult university ICU setting.

  Determined by a stratified clustered hierarchical win ratio. Patient data is clustered by ICU sub-unit and stratified by APACHE score. For each stratum, each patient in the study group is compared with all patients in the control group within that same stratum. Levels are assessed up to 28 days after admission. The hierarchical levels are: 1. All-cause mortality; 2. Number of organ systems failed (respiratory, cardiovascular, coagulation, liver, renal) with SOFA scores newly increasing to 3 points during the ICU stay; and 3. Sum of highest circulatory and respiratory SOFA scores during the ICU stay, independently assessed and subsequently summed. If one patient "wins" at the first level (i.e., is alive while the other is dead), the comparison is decided. If a tie occurs (both alive or both dead at at 28 days), the next level is compared, and so forth. This approach prioritizes the most clinically serious outcome (mortality), while capturing organ dysfunction at different levels.

  Patient data up to 28 days post admission will be collected to support analysis.

Secondary Outcomes (4)

• Time free of circulatory failure and alive at 28 days

  Patient data up to 28 days post admission will be collected to support analysis.

• Time free of respiratory failure and alive at 28 days

  Patient data up to 28 days post admission will be collected to support analysis.

• All cause mortality at 28 days

  Patient data up to 28 days post admission will be collected to support analysis.

• Mean total SOFA score over ICU stay

  Patient data up to 28 days post admission will be collected to support analysis.

Study Arms (2)

Control Group

Patients are admitted to the ICU and received the standard of care without the availability of Beacon

Study Group

Patients are admitted to the ICU and received the standard of care with the additional availability of Beacon by treating clinicians.

Other: ICU Beacon

Interventions

ICU Beacon OTHER

Availability of a proprietary clinician awareness for potential organ deterioration software to treating clinicians (ICU Beacon) in addition to the standard of care.

Also known as: Beacon

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes all patients admitted to the Inselspital Bern ICU, not fulfilling any of the exclusion criteria.

You may qualify if:

• admission to intensive care unit

You may not qualify if:

• age \< 18 years
• presence of documented refused general consent form (at database closure)
• admission for the sole purpose of dying/organ donation or evaluation of such

Sponsors & Collaborators

• ETH Zurich: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Shock; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gunnar Rätsch, Dr. rer. nat.

CONTACT

+41 44 632 2036; raetsch@ethz.ch

Quinten Johnson

CONTACT

+41 78 300 9997; quinten.johnson@inf.ethz.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 13, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-06

Locations

CH (1)