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Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation (ONWARD - AV)

10. juni 2026 opdateret af: Eske Kvanner Aasvang

Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients

The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.

The study will focus on adult, hospitalized patients who are monitored at the general hospital ward with continuous, real-time vital sign monitoring combined with the WARD-CSS (WARD clinical support system) that relays alerts to the clinical staff in case of significant deviations. The evaluation focus on the user perceived relevance and usefulness of the alerts generated by the system which includes a proprietary novel alerts logic. Specifically, investigators aim to assess how users evaluate the clinical relevance of triggered change-based alerts and the helpfulness of the accompanying alert descriptions.

During monitoring, the app will be used according to the intended use and additionally two questions will be prompted if alerts are sent.

Patients monitored will have an expected length of stay at the hospital, which supports at least one day of continuous monitoring. Readings from the WARD-CSS is not blinded for treating staff to get feedback on the use of the application. This study will include up to 100 patients.

An alerting feedback questionnaire will be constructed as simple feedback buttons/sliders, prompted after an alert is 'accepted' in the app. The feedback buttons will only be prompted for a representative proportion of the alerts. This will be done at random based on the alert frequencies determined in the retrospective analysis. This way, a close to equal amount of feedback responses will be prompted and obtained for different alert types with different occurrences. The feedback will be linked to the alert in the app, such that feedback can be submitted at any point in time, thus not disturbing the nurse while medical intervention is provided.

The feedback will be constructed with the following two interactions for the clinical staff.

  • Alert relevance in relation to deterioration of the patient (5-point Likert scale).
  • Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care (5-point Likert scale)

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2100
        • Rigshospitalet
      • Copenhagen, Danmark, 2400
        • Bispebjerg Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion criteria:

Patients can be included if they meet all the following criteria:

  • Age ≥ 18 years
  • Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration.
  • Expected admission for more than 24 hours to a general ward.

Exclusion criteria:

Patients are excluded if they meet any of the following criteria:

  • Having implanted electronic devices (such as pacemaker or Implantable Cardioverter Defibrillator (ICD) device).
  • Known pregnancy or breastfeeding
  • Inability to give informed consent.
  • The participant expected not to cooperate with study procedures.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Adult, hospitalized patients who are monitored for vital signs in the general wards
Enhed: Continuous vital sign monitoring
The intervention involves continuous, real-time vital sign monitoring using sensors to measure vital signs combined with WARD-CSS and novel algorithms designed to detect clinically relevant deviations in the vital signs.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relevance of alerts
Tidsramme: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.

The staff evaluated relevance of alerts triggered during continuous vital signs monitoring

Evaluated by 5-point Likert scale:

1. Not relevant 2 Slightly relevant 3 Moderately relevant 4 Relevant 5 Highly Relevant
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relevance of the description
Tidsramme: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.

Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care

Evaluated by 5-point Likert scale:

  1. Strongly Disagree
  2. Disagree 3- Undecided

4 Agree 5 Strongly Agree
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Alert rate
Tidsramme: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
Total alert rate, including false alert rate, of the WARD-CSS.
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
Postoperative complications
Tidsramme: 30 days
Postoperative complications, defined by internationally agreed criteria
30 days
Heart rate (measured in beats per minute (BPM))
Tidsramme: 7 days
Collected continuously
7 days
SpO2 (blood oxygen saturation, measured in percentage)
Tidsramme: 7 days
Collected continuously
7 days
Blood pressure (measured in mmHg)
Tidsramme: 7 days
Collected continuously
7 days
Respiration Rate (measured in BrPM)
Tidsramme: 7 days
Collected continuously
7 days
Pulse (measured in BPM)
Tidsramme: 7 days
Peripheral pulse - Collected continuously
7 days
Temperature (measured in degrees Celcius)
Tidsramme: 7 days
Collected continuously
7 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eske Kvanner Aasvang

Samarbejdspartnere

Rigshospitalet, Denmark
University Hospital Bispebjerg and Frederiksberg

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

28. maj 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

31. marts 2028

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2502107 (MREC)
  • 2025071987 (Anden identifikator: DMA)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Data access can be discussed upon request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Postoperativ pleje

Kliniske forsøg med Continuous vital sign monitoring

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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