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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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)
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eske K Aasvang, DMSci
- Número de teléfono: +4526232076
- Correo electrónico: Eske.Kvanner.Aasvang.01@regionh.dk
Copia de seguridad de contactos de estudio
- Nombre: Aslak B Johansen, M.D.
- Número de teléfono: +4522952551
- Correo electrónico: aslak.broby.johansen@regionh.dk
Ubicaciones de estudio
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Copenhagen, Dinamarca, 2100
- Rigshospitalet
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Copenhagen, Dinamarca, 2400
- Bispebjerg Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Relevance of alerts
Periodo de tiempo: 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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Relevance of the description
Periodo de tiempo: 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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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.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Alert rate
Periodo de tiempo: 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.
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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
Periodo de tiempo: 30 days
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Postoperative complications, defined by internationally agreed criteria
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30 days
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Heart rate (measured in beats per minute (BPM))
Periodo de tiempo: 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)
Periodo de tiempo: 7 days
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Collected continuously
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7 days
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Blood pressure (measured in mmHg)
Periodo de tiempo: 7 days
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Collected continuously
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7 days
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Respiration Rate (measured in BrPM)
Periodo de tiempo: 7 days
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Collected continuously
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7 days
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Pulse (measured in BPM)
Periodo de tiempo: 7 days
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Peripheral pulse - Collected continuously
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7 days
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Temperature (measured in degrees Celcius)
Periodo de tiempo: 7 days
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Collected continuously
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7 days
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2502107 (MREC)
- 2025071987 (Otro identificador: DMA)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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