- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04827342
Feasibility and Functionality Test of Ada's DDSS Prototype (Ada4dyspnoe)
Feasibility and Functionality Test of Ada's DDSS Prototype, Exploring the Potential and Performance When Diagnosing Complex Cases of Dyspnea at the Emergency Department and Ward of Interna! Medicine of the University Hospital Basel
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is an observational i.e. non-interventional, prospective feasibility study, which assesses, through observation, the potential, functionality and diagnostic performance of the Ada DDSS prototype in evaluating patients presenting with dyspnea as primary predominant complaint to the ED.
Once the consent form is signed, the Investigator documents patients' data, medical history, symptoms and findings with the Ada DDSS prototype. During the entire patient journey through the hospital (presentation at the ED through to admission in the ward of Internal Medicine) relevant information are collected and documented in the Ada DDSS prototype simultaneously to standard documentation by the medical staff.
Examination and treatment are carried out by the attending physician without being influenced or affected by the entry of data in the Ada DDSS prototype.
There is no intervention/change made to the usual care, and therefore neither an intervention patient group nor a control patient group. The "usual care" that each patient receives is the control comparison point for the performance of the Ada DDSS. The diagnoses proposed by the tool at different times (after triage in the emergency centre, when transferred to the ward and when discharged from the hospital) are then compared with those of the attending physician.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Basel, Suiza, 4031
- University Hospital Basel
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Dyspnea as the main symptom when entering the emergency room
- Existence of written consent
- The patient is able to speak, understand and read German or English.
Exclusion Criteria:
- Inability or unwillingness to understand and comply with study procedures due to:
- Language problems
- Acute mental disorders
- Dementia
- Clinical instability (e..B. resuscitation treatment, non-invasive ventilation, etc.)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility of the Ada DDSS prototype
Periodo de tiempo: during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
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Feasibility of the Ada DDSS prototype simultaneously to standard documentation by the medical staff.
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during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
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Subjectively perceived benefit from using the Ada DDSS prototype
Periodo de tiempo: during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
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Subjectively perceived benefit from using the Ada DDSS prototype (during patient journey in the hospital) assessed by a physician.
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during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jens Eckstein, Prof. Dr. med., University Hospital, Basel, Switzerland
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 2020-00095; me19Eckstein3
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .