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Development of an Early Warning Score for Detecting the Deterioration of a Patients' General Condition in an Acute Hospital

Investigator-initiated, Retrospective, Single-center Study for the Development of an Early Warning Score for Detecting the Deterioration of a Patients' General Condition in an Acute Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05639452
Enrollment
210
Registered
2022-12-06
Start date
2022-10-05
Completion date
2023-10-31
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Condition

Keywords

Early Warning Score (EWS), Deterioration of Patients' General Condition

Brief summary

An acute deterioration of a patients' general condition is often preceded by changes in individual vital parameters. An early warning system (EWS) shall be developed with a reduced number of physiological and individual parameters, compared to conventional early warning systems; and an algorithm will be generated that is able to predict clinical deterioration. Its predictive power and accuracy shall be investigated. In a second exploratory phase, different model variants will be analyzed and the applicability of the model variants in the context of continuous EWS on wearables will be examined.

Detailed description

An acute deterioration of a patients' general condition is often preceded by changes in individual vital parameters and may lead to adverse events, such as admission to the intensive care unit, heart attack or death. Some of them are potentially avoidable if appropriate measures are taken in a timely manner. Therefore early warning systems (Early Warning Scores= EWS) have been developed from a set of several physiological measurements, signs and symptoms. Individual parameters are weighted to sum up a score. Based on this score, the deterioration of a patients' general condition may be indicated and a predetermined reaction from the professional staff be triggered (so-called track-and-trigger system). It is important to determine all parameters since missing values influence the informative value of an EWS. This requires a higher effort by the staff and is one of the reasons why early warning systems are not yet used systematically in Switzerland. A reduction in the number of parameters to be measured could lower the hurdle for the use of these tools and enable a broader applicability. Therefore an early warning system shall be developed with a reduced number of physiological and individual parameters, compared to conventional early warning systems; and an algorithm will be generated that is able to predict clinical deterioration. Its predictive power and accuracy shall be investigated, based on various clinical outcomes such as mortality, cardiac arrest, transfer to the intensive care unit or sepsis. Retrospective, encrypted patient data (from 2016 until 2022) will be used to develop a statistical prediction model. In a second exploratory phase, different model variants will be analyzed and the applicability of the model variants in the context of continuous EWS on wearables will be examined.

Interventions

OTHERData collection for developing an algorithm for an Early Warning Score

Data collection of patient parameters (heart rate, respiratory rate, clinical outcomes (death, transfer to intensive care unit, adverse events like sepsis, infection, heart attack))

Sponsors

Innosuisse - Swiss Innovation Agency
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospitalized patients of surgical and medical wards of University Hospital Basel * Hospital stay longer than 24 hours * Signed general consent

Exclusion criteria

* Patients admitted directly to the intensive care unit * Rejection of general consent

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Early Warning Scoreup to 72 hours after hospital admissionThe accuracy of the early warning system in terms of its predictive power is measured by using the respective medical outcomes. Data models are used to create a relationship between the patient parameters (the predictors) and the clinical outcome (Condition stable vs. condition unstable: death, transfer to intensive care unit, heart attack, infection/sepsis, etc.) as a binary response variable (whether a deterioration occurs or not).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026