ICU Background Early Awareness for Critical deterioratiON (BEACON)

ICU Background Early Awareness for Critical deterioratiON (BEACON)

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.

Study Overview

• Status: Recruiting
• Conditions: Mortality; Respiratory Failure; Circulatory Failure; Organ Dysfunction; Organ Failure, Multiple
• Intervention / Treatment: Other: ICU Beacon

Detailed Description

Single-center, stratified, cluster-randomized (the ICU units will be randomized) crossover analysis with outcome-assessor blinding. The analysis will be conducted in the adult intensive care units (ICUs) of Inselspital, Bern, comprising two distinct ICU units: the Blue and the Yellow ICU Unit. Each unit contains two sub-units, which will serve as the clustering units for randomization. The study follows a two-phase design. In the initial phase, sub-units within each ICU unit will be randomly allocated in a 1:1 ratio to either the additional BEACON scoring group or control group. Patients admitted to sub-units allocated to the BEACON group will receive standard care plus BEACON scores, while those admitted to control group will receive standard care only. After predefined cluster periods, allocations will be swapped between the BEACON and control groups. A wash-out period of two weeks will be observed between swaps to minimize carryover effects. During the wash-out period, no new study patients will be enrolled. Once the swap is complete, only newly admitted patients will be enrolled under the sub-unit's new allocation. Patients still occupying sub-units from the preceding period will be censored from the study at the time of the swap and excluded from outcome analysis beyond that point. The same approach will be applied for patients who will be transferred from one unit to a different unit during the ICU admission for logistical/organizational reasons. Importantly, individual patients will only be exposed to one analysis condition-either the BEACON or control-based on the bed allocation at the time of their admission. Only the sub-units themselves undergo crossover, ensuring temporal balance while maintaining patient-level exposure to a single condition.

• Study Type: Observational
• Enrollment (Estimated): 1962

Contacts and Locations

• Study Contact: Name: Gunnar Rätsch, Dr. rer. nat.; Phone Number: +41 44 632 2036; Email: raetsch@ethz.ch
• Study Contact Backup: Name: Quinten Johnson; Phone Number: +41 78 300 9997; Email: quinten.johnson@inf.ethz.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital - Universitätsspital Bern
    • Contact: Martin Faltys, Dr. med.; Phone Number: +41 31 632 2111; Email: martin.faltys@insel.ch
    • Principal Investigator: Martin Faltys, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• admission to intensive care unit

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Availability of a proprietary clinician awareness for potential organ deterioration software to treating clinicians (ICU Beacon) in addition to the standard of care.; Other Names: Beacon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: All-cause mortality;; Number of organ systems failed (respiratory, cardiovascular, coagulation, liver, renal) with SOFA scores newly increasing to 3 points during the ICU stay; and; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time free of circulatory failure and alive at 28 days	Described by the total number of days the patient was alive and free of circulatory failure within the first 28 days after admission. Circulatory failure is defined as: lactate >= 2 mmol/L and MAP <= 65 mmHg or receipt of vasopressors/inotropes.	Patient data up to 28 days post admission will be collected to support analysis.
Time free of respiratory failure and alive at 28 days	Described by the total number of days the patient was alive and free of respiratory failure within the first 28 days after admission. Respiratory failure is defined as: (PaO2/FiO2 ratio < 150 mmHg).	Patient data up to 28 days post admission will be collected to support analysis.
All cause mortality at 28 days	Mortality from any cause within 28 days following ICU admission.	Patient data up to 28 days post admission will be collected to support analysis.
Mean total SOFA score over ICU stay	The mean SOFA score including all organ systems through the duration of the ICU admission.	Patient data up to 28 days post admission will be collected to support analysis.

Collaborators and Investigators

• Sponsor: ETH Zurich
• Collaborators: Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: July 16, 2025
• First Submitted That Met QC Criteria: August 5, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: prevention; respiratory failure; prediction; risk prediction; circulatory failure; organ failure; multi-organ failure; icu; early warning system; win-ratio; ICU Beacon
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Shock; Multiple Organ Failure
• Other Study ID Numbers: BASEC 2025-00623

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No