Deterioration of Patient's State of HealthNCT05699967
Development of an Automatically Generated and Wearable-based Early Warning System
An observational study of Deterioration of Patient's State of Health, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deterioration of Patient's State of Health
- What is being tested?
- data collection
- How many people
- 210 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Feb 2023to 14 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients will be recruited at the University Hospital Basel (USB). Potential patients will be approached during their ward stay.
Who may be able to join
- Planned hospital stay > 24 hours
- Written informed consent as documented by signature from the participant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Internal Medicine
Basel, 4031
About this study
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
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.
Read the 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.
- Being tested
- data collection
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one time assessment at Day 1
Secondary outcomes (3)
Compliance of the study subjects concerning the wearable device
Compliance of the study subjects evaluated by the time the wearable was effectively worn by the patient divided by the time the wearable was supposed to be worn by the participant
Measured: one time assessment at Day 1
Patient acceptance of the approach
Participants' feedback about the approach collected by a semi structured interview
Measured: one time assessment at Day 1
Number of incomplete datasets
Number of incomplete datasets for analysis of the technical feasibility and practical usability
Measured: one time assessment at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start7 Feb 2023
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deterioration of Patient's State of HealthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Innosuisse - Swiss Innovation Agency
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, Prof. Dr. med., Principal investigator, University Hospital Basel, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699967
- Sponsor's protocol ID
- 2022-02093; am22Eckstein5
- Status last verified
- Oct 2023
- First submitted
- 17 Jan 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39380078
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05699967
- Acronym / sponsor ID
- 2022-02093; am22Eckstein5
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Innosuisse - Swiss Innovation Agency
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 26 Jan 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be recruited at the University Hospital Basel (USB). Potential patients will be approached during their ward stay.
Key inclusion criteria (2 listed)
- Planned hospital stay > 24 hours
- Written informed consent as documented by signature from the participant
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| data collectionParticipants 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. | Other | – |
Primary outcome
Number of correctly automatically calculated scores
Time frame: one time assessment at Day 1
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.
3 secondary outcomes
Compliance of the study subjects concerning the wearable device
Time frame: one time assessment at Day 1
Patient acceptance of the approach
Time frame: one time assessment at Day 1
Number of incomplete datasets
Time frame: one time assessment at Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 39380078Reichl 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.
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. This study is not recruiting at the moment.
Jens Eckstein, Prof. Dr. med. principal investigator
University Hospital Basel, Department of Internal Medicine
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 Deterioration of Patient's State of Health, run by University Hospital, Basel, Switzerland 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 2 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: finished, as of the sponsor's last update on 5 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of correctly automatically calculated scores (time frame: one time assessment at Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05699967, which also lists 1 linked publication.
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 5 Oct 2023.