Clinical trial NCT05699967: Development of an Automatically Generated and Wearable-based Early Warning System
Official title: Pilot Project for the Development of an Automatically Generated and Wearable-based Early Warning System for the Detection of Deterioration of Hospitalized Patients of an Acute Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deterioration of Patient's State of Health
Keywords: wearable-based early warning system
Early Warning Score (EWS)
vital signs
automated EWS
wearable device
National Early Warning Score 2 (NEWS2)
automated data collection
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Innosuisse - Swiss Innovation Agency
First posted: 2023-01-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients will be recruited at the University Hospital Basel (USB). Potential patients will be approached during their ward stay.

Brief summary: The aim of this project is to create an automated EWS and analyze whether the use of wearable devices is suitable for vital sign measurements in a hospital by using the recording of vital parameters taken by nurses via the Clinical Information System (HIS) combining them with vital sign measurements coming from wearable devices.

Detailed description: Acute deteriorations of patients are often preceded by changes in their vital signs and can thus lead to adverse events in hospital wards. Some of these events may be preventable if the deterioration is detected in time and appropriate measures are taken. Early Warning Scores (EWS) have been developed to systematically assess the vital signs of all patients. There are different versions of EWS but all of the systems have the same purpose: they are intended to timely identify the risk of patients deteriorating by monitoring the health status of patients during their hospital stay on the basis of routinely measured vital signs by ward staff. The EWS is an aggregated scoring system, the higher the score, the higher the risk of a deterioration. EWS have limitations as classical EWS are userdependent systems prone to incomplete recordings, calculation errors in the EWS and nonadherence to referral protocols. The aim of this project is to create an automated EWS and analyze whether the use of wearable devices is suitable for vital sign measurements in a hospital by using the recording of vital parameters taken by nurses via the Clinical Information System (HIS) combining them with vital sign measurements coming from wearable devices. The National Early Warning Score 2 (NEWS2), which was developed to standardize the approach to detection of clinical deterioration, shall be used. The NEWS2 is a predictive scoring system that uses 6 physiological parameters: heart rate (HR), respiratory rate (RR), oxygen saturation levels (SpO2) including supplemental oxygen, systolic blood pressure, temperature and level of consciousness. A score of 0, 1, 2 or 3 is allocated to each parameter. A higher score means the parameter is further from the normal range. The NEWS2 is then constituted by combining the individual scores of every parameter to an aggregated score, the NEWS2 Score.

Mobile sensors (wearables) are able to monitor some of the components of the EWS and their use has the potential to provide timely information on the patient's health status thanks to continuous automated data collection, especially with regard to vital signs like the respiratory rate. This study is to make a first step towards the development of an application which automatically generates the National Early Warning Score 2 (NEWS2) using the recordings of vital parameters via wearables and combining them with data documented in the Clinical Information System and to evaluate the feasibility of this application in terms of accuracy of the calculated scores.

Eligibility criteria: Inclusion Criteria:

* Planned hospital stay \> 24 hours
* Written informed consent as documented by signature from the participant

Exclusion Criteria:

* Unable or not willing to sign informed consent
* Wearable cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, excessive hairiness, edema, venous access, other)
* Significant mental or cognitive impairment

Primary outcomes:
measure: Number of correctly automatically calculated scores
timeFrame: one time assessment at Day 1
Secondary outcomes:
measure: Compliance of the study subjects concerning the wearable device
timeFrame: one time assessment at Day 1
measure: Patient acceptance of the approach
timeFrame: one time assessment at Day 1
measure: Number of incomplete datasets
timeFrame: one time assessment at Day 1
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Internal Medicine
Study officials:
affiliation: University Hospital Basel, Department of Internal Medicine
name: Jens Eckstein, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: