NCT05699967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

January 17, 2023

Last Update Submit

October 4, 2023

Conditions

Deterioration of Patient's State of Health

Keywords

wearable-based early warning systemEarly Warning Score (EWS)vital signsautomated EWSwearable deviceNational Early Warning Score 2 (NEWS2)automated data collection

Outcome Measures

Primary Outcomes (1)

  • Number of correctly automatically calculated scores

    Comparing the NEWS2 calculated with values from the EHR and the automatically calculated NEWS2 with values from the EHR and wearable devices: The number of correctly automatically calculated scores will be assessed.

    one time assessment at Day 1

Secondary Outcomes (3)

  • Compliance of the study subjects concerning the wearable device

    one time assessment at Day 1

  • Patient acceptance of the approach

    one time assessment at Day 1

  • Number of incomplete datasets

    one time assessment at Day 1

Interventions

data collectionOTHER

Participants wear a wristband with a Photoplethysmography (PPG), heart rate and respiratory rate sensor continuously for 3 days. Once gateway and device are linked, all data will be transmitted continuously via Bluetooth to an in-house database. The Device Hub allows to control data availability and signal quality of the wearables, but no scores will be calculated and visualized. The data obtained for calculating the NEWS2 is solely observational and for the study staff. It has no clinical consequence on the treatment of the patient. It is analyzed whether the score with values form the wearables and Electronic Health Record (EHR) corresponds to the conventionally calculated NEWS2 score with values coming only from the EHR.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients will be recruited at the University Hospital Basel (USB). Potential patients will be approached during their ward stay.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Division of Internal Medicine

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Reichl JJ, Leifke M, Wehrli S, Kunz D, Geissmann L, Broisch S, Illien M, Wellauer D, von Dach N, Diener S, Manser V, Herren V, Angerer A, Hirsch S, Holz B, Eckstein J. Pilot study 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. Arch Public Health. 2024 Oct 8;82(1):179. doi: 10.1186/s13690-024-01409-y.

    PMID: 39380078DERIVED

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jens Eckstein, Prof. Dr. med.

    University Hospital Basel, Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

February 7, 2023

Primary Completion

September 14, 2023

Study Completion

September 14, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

CH(1)