Respiratory FailureBEACONNCT07119411
ICU Background Early Awareness for Critical deterioratiON
An observational study of Respiratory Failure and Circulatory Failure, run by ETH Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure, Circulatory Failure, Mortality
- What is being tested?
- ICU Beacon
- How many people
- 1,962 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2025to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes all patients admitted to the Inselspital Bern ICU, not fulfilling any of the exclusion criteria.
Who may be able to join
- admission to intensive care unit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital - Universitätsspital Bern
Bern, 3010
Martin Faltys, Dr. med., +41 31 632 2111, martin.faltys@insel.ch
Martin Faltys, Dr. med.
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Failure, Circulatory Failure, Mortality, Organ Dysfunction, Organ Failure, Multiple
- Being tested
- ICU Beacon
- Keywords
- icu, respiratory failure, circulatory failure, early warning system, prevention, prediction, risk prediction, organ failure, multi-organ failure, win-ratio, ICU Beacon
- Medical subject headings
- Respiratory Insufficiency, Shock, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU BeaconOther
Also called Beacon
Availability of a proprietary clinician awareness for potential organ deterioration software to treating clinicians (ICU Beacon) in addition to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ICU Beacon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Patient data up to 28 days post admission will be collected to support analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Dec 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,962 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETH Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119411
- Sponsor's protocol ID
- BASEC 2025-00623
- Acronym
- BEACON
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Background Early Awareness for Critical deterioratiON (BEACON)
- ClinicalTrials.gov ID
- NCT07119411
- Acronym / sponsor ID
- BEACON / BASEC 2025-00623
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,962 participants (estimated)
- Lead sponsor
- ETH ZurichUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Patients are admitted to the ICU and received the standard of care without the availability of Beacon |
| Study Group | – | Other: ICU BeaconPatients are admitted to the ICU and received the standard of care with the additional availability of Beacon by treating clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes all patients admitted to the Inselspital Bern ICU, not fulfilling any of the exclusion criteria.
Key inclusion criteria (1 listed)
- admission to intensive care unit
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU BeaconAlso: BeaconAvailability of a proprietary clinician awareness for potential organ deterioration software to treating clinicians (ICU Beacon) in addition to the standard of care. | Other | Study Group |
Primary outcome
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.
Time frame: Patient data up to 28 days post admission will be collected to support analysis.
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.
4 secondary outcomes
Time free of circulatory failure and alive at 28 days
Time frame: Patient data up to 28 days post admission will be collected to support analysis.
Time free of respiratory failure and alive at 28 days
Time frame: Patient data up to 28 days post admission will be collected to support analysis.
All cause mortality at 28 days
Time frame: Patient data up to 28 days post admission will be collected to support analysis.
Mean total SOFA score over ICU stay
Time frame: Patient data up to 28 days post admission will be collected to support analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Circulatory Failure, run by ETH Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gunnar Rätsch, Dr. rer. nat. (+41 44 632 2036, raetsch@ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Patient data up to 28 days post admission will be collected to support analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.