ICU Background Early Awareness for Critical deterioratiON

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1962 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-04

Study Completion Date

2027-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Failure Circulatory Failure Mortality Organ Dysfunction Organ Failure, Multiple

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

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

No interventions assigned to this group

Study Group

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

ICU Beacon

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Beacon

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes