Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation (ONWARD - AV)
Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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)
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eske K Aasvang, DMSci
- Numéro de téléphone: +4526232076
- E-mail: Eske.Kvanner.Aasvang.01@regionh.dk
Sauvegarde des contacts de l'étude
- Nom: Aslak B Johansen, M.D.
- Numéro de téléphone: +4522952551
- E-mail: aslak.broby.johansen@regionh.dk
Lieux d'étude
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Copenhagen, Danemark, 2100
- Rigshospitalet
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Copenhagen, Danemark, 2400
- Bispebjerg Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Adult, hospitalized patients who are monitored for vital signs in the general wards
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Relevance of alerts
Délai: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Relevance of the description
Délai: 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:
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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Alert rate
Délai: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
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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.
|
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Postoperative complications
Délai: 30 days
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Postoperative complications, defined by internationally agreed criteria
|
30 days
|
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Heart rate (measured in beats per minute (BPM))
Délai: 7 days
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Collected continuously
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7 days
|
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SpO2 (blood oxygen saturation, measured in percentage)
Délai: 7 days
|
Collected continuously
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7 days
|
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Blood pressure (measured in mmHg)
Délai: 7 days
|
Collected continuously
|
7 days
|
|
Respiration Rate (measured in BrPM)
Délai: 7 days
|
Collected continuously
|
7 days
|
|
Pulse (measured in BPM)
Délai: 7 days
|
Peripheral pulse - Collected continuously
|
7 days
|
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Temperature (measured in degrees Celcius)
Délai: 7 days
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Collected continuously
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7 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2502107 (MREC)
- 2025071987 (Autre identifiant: DMA)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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