- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02184793
Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit (Inclinometre2)
Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.
The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and 50°) is an international guidance to prevent ventilator-associated pneumopathy which is the main nosocomial infection in intensive care unit. However, maintaining such an inclination has been shown to be difficult in day-to-day care.
This could be improved by using an assistance device that would measure inclination of the head of bed in real time and trigger an alarm when the value order is not reached, hence allowing a quick readjustment if necessary.
The investigators want to evaluate en electronic monitoring device (EMD) that is removable and adjustable to all beds, which would allow a whole intensive care unit to be fully equipped at low cost.
Hypothesis : using an EMD could improve the proportion of time spent per day in semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in mechanically-ventilated patients.
Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
Secondary objectives :
- to evaluate the impact of the EMD on the head of bed inclination overall mean
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination superior to 30°
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination between 30° and 45°
- to study factors associated to a head of bed inclination inferior to 30° for more than 12hrs per 24hrs
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Paris, Francia, 75018
- Hopital Bichat Claude Bernard
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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 with invasive mechanical ventilation
- expected mechanical ventilation duration for more than 48h after inclusion
- signature of an informed consent by a relative
- patient affiliated to a social security scheme (beneficiary or assignee)
Exclusion Criteria:
- age<18 years old
- mechanical ventilation with tracheotomy
- contraindication to semirecumbent position (e.g., spinal cord injury, important sacral bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation) or expected indication to another position within the following 48 h after inclusion (e.g., ventral decubitus for hypoxemia pulmonary pathology)
- SAPS II score > 65 at the admission (moribund patients)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: EMD (Inclinomax) then usual care
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h. Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h. |
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on
Otros nombres:
|
Otro: usual care then EMD (Inclinomax)
Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h. EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h. |
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50°
Periodo de tiempo: 24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
head of bed inclination overall mean
Periodo de tiempo: 24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
proportion of time spent per day with a head of bed inclination superior to 30°
Periodo de tiempo: 24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
proportion of time spent per day with a head of bed inclination between 30° and 45°
Periodo de tiempo: 24hrs
|
head of bed inclination recording during 24h
|
24hrs
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lila BOUADMA, MD, Assistance Publique - Hôpitaux de Paris
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- P080407
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. .
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