- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04053179
Validation of a Connected Patch, an Alternative to Conventional Monitoring
Descripción general del estudio
Descripción detallada
When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring.
The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team.
One of the crucial issues is therefore the speed of the alarm and its reliability.
The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower.
The connected patch used in this research is the Scaléo Médical company's device "myAngel VitalSigns". The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project.
The objective of this research is therefore to validate Scaléo Médical's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Suresnes, Francia, 92150
- Hopital Foch
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patient over 18 and under 85 years of age
- patient requiring general anesthesia for extra-thoracic surgery
- the patient's position during the operation is in supine position only
- patient affiliated to or benefiting from social security, excluding State Medical Assistance
- patient with written consent
Exclusion Criteria:
- pregnant or breastfeeding patients
- patients known to have severe skin reactions to adhésives
- patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
- patients deprived of their liberty or under guardianship
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- 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: Validación de parches conectados
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Uso de parche conectado para recoger la presión arterial, la frecuencia cardíaca, la frecuencia respiratoria, la saturación de oxígeno arterial y la temperatura
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Concordance of blood pressure value measured by 2 different devices after surgery
Periodo de tiempo: 36 hours maximum after the surgery
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Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
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36 hours maximum after the surgery
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Concordance of heart rate value measured by 2 different devices after surgery
Periodo de tiempo: 36 hours maximum after the surgery
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Comparison between heart rate measured by conventional medical monitoring device and by connected patch
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36 hours maximum after the surgery
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Concordance of respiratory rate value measured by 2 different devices after surgery
Periodo de tiempo: 36 hours maximum after the surgery
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Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
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36 hours maximum after the surgery
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Concordance of arterial oxygen saturation value measured by 2 different devices after surgery
Periodo de tiempo: 36 hours maximum after the surgery
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Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
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36 hours maximum after the surgery
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Concordance of temperature value measured by 2 different devices after surgery
Periodo de tiempo: 36 hours maximum after the surgery
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Comparison between temperature measured by conventional medical monitoring device and by connected patch
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36 hours maximum after the surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Concordance of blood pressure value measured by 2 different devices during surgery
Periodo de tiempo: During surgery
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Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
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During surgery
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Concordance of heart rate value measured by 2 different devices during surgery
Periodo de tiempo: During surgery
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Comparison between heart rate measured by conventional medical monitoring device and by connected patch
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During surgery
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Concordance of respiratory rate value measured by 2 different devices during surgery
Periodo de tiempo: During surgery
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Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
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During surgery
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Concordance of arterial oxygen saturation value measured by 2 different devices during surgery
Periodo de tiempo: During surgery
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Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
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During surgery
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Concordance of temperature value measured by 2 different devices during surgery
Periodo de tiempo: During surgery
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Comparison between temperature value measured by conventional medical monitoring device and by connected patch
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During surgery
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Blood pressure artifact
Periodo de tiempo: From surgery to 36 hours maximum after the surgery
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Value of blood pressure will be considered as artifact if systolic blood pressure value < 80 or > 200 and diastolic blood pressure > 110
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From surgery to 36 hours maximum after the surgery
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Heart rate artifact
Periodo de tiempo: From surgery to 36 hours maximum after the surgery
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Value of heart rate will be considered as artifact if value < 40 or > 140
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From surgery to 36 hours maximum after the surgery
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Respiratory rate artifact
Periodo de tiempo: From surgery to 36 hours maximum after the surgery
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Value of respiratory rate will be considered as artifact if value < 8 or > 36
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From surgery to 36 hours maximum after the surgery
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Arterial oxygen saturation artifact
Periodo de tiempo: From surgery to 36 hours maximum after the surgery
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Value of arterial oxygen saturation will be considered as artifact if value < 85 %
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From surgery to 36 hours maximum after the surgery
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Acceptability of connected patch: numerical scale
Periodo de tiempo: During the surgery and through study completion
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Evaluation of connected patch with a simple numerical scale between 0 and 10: 0 representing a very poor tolerance of the device and leading to premature interruption of the collection and 10 a perfect tolerance allowing the patch to be maintained for several consecutive days
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During the surgery and through study completion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Morgan Le Guen, Hopital Foch
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- 2017055F
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
producto fabricado y exportado desde los 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. .
Ensayos clínicos sobre Validación de parches
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Central Michigan UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... y otros colaboradoresTerminadoObesidad InfantilEstados Unidos
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Chang Gung Memorial HospitalNational Yang Ming UniversityDesconocidoAnálisis de sueño-vigilia
-
EvergreenHealthTerminadoFibrilación auricular | Síncope | Taquicardia supraventricular | PresíncopeEstados Unidos
-
Universitaire Ziekenhuizen KU LeuvenBytefliesActivo, no reclutando
-
Element Science, Inc.Inscripción por invitación
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St. Justine's HospitalAún no reclutando
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Yonsei UniversityReclutamientoMonitoreo continuo de EKG usando S-Patch Ex: estudio observacional prospectivo (registro de S-patch)Paciente con Fibrilación Auricular o Alto Riesgo de IctusCorea, república de
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Yonsei UniversityAún no reclutandoFibrilación/aleteo auricular en pacientes con alto riesgo de accidente cerebrovascularCorea, república de
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Mughal Eye Trust HospitalDesconocidoEstrabismo | AmbliopíaPakistán