- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03348579
Hospital-acquired Pneumonia in Intensive Care Unit (PNEUMOCARE)
Hospital Acquired and Ventilator Associated Pneumonia : Impact of the New French Guidelines on Patients Care and Outcomes.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The before period (phase 1) will consist of all consecutive patients admitted to the participating ICUs before the national guidelines publication concerning healthcare associated pneumonia.
The second period (phase 2) will consist of all consecutive patients admitted to the participating ICUs after the publication of the national guidelines publication concerning healthcare associated pneumonia.
Afterward, an interphase will occur during which all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the new guidelines published in september 2017.
In the intervention group, on top of the standard training, the centers receive an analysis of the evolution of the practices of their center and the future of their patients between phases 1 and 2, as well as these same values for the data set. The centers are then called to conduct a meeting to determine their priority improvement points based on this audit.
The third and final period (phase 3) will consist of all consecutive patients admitted to the participating ICUs after the formal training.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Nantes, Francia, 44093
- CHU de Nantes
-
-
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:
- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days
Exclusion Criteria:
- Community-acquired pneumonia, pregnant women, refusal to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
The before period
The before period (control phase) will consist of all consecutive patients admitted to the participating ICUs before the national guidelines publication concerning hospital-acquired pneumonia.
|
Passing recommendations on using the guidelines in the intensive care units
|
|
The second period
Intensive care units are randomized in two groups: Standard training: The centers will receive the text of the recommendation electronically. The principal investigator of each center will then train doctors, interns, nurses and physiotherapists to the use of these recommendations (team leader). A computer presentation common to all the centers will be used and a communication strategy vis-à-vis the other caregivers of the investigative services will be put in place. All doctors, interns and nurses must have attended this theoretical training during the awareness phase. |
Passing recommendations on using the guidelines in the intensive care units
Targeted experience feedback": On top of the standard training, the centers receive an analysis of the evolution of the practices of their center and the future of their patients between phases 1 and 2, as well as these same values for the data set.
The centers are then called to conduct a meeting to determine their priority improvement points based on this audi
|
|
The third and final period
The third and final period will consist of all consecutive patients admitted to the participating ICUs after the formal training.
|
Passing recommendations on using the guidelines in the intensive care units
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Unit length of stay
Periodo de tiempo: 28 days
|
Duration of ICU hospitalization Safety Issue: NA
|
28 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intensive Care Unit free-days at day 28
Periodo de tiempo: 28 days
|
The number of days from day 1 to day 28 on which a patient is alive outside of intensive care unit Safety Issue
|
28 days
|
|
Hospital-acquired pneumonia
Periodo de tiempo: 28 days
|
definition based on the appearance of a new infiltrate or changes in an existing infiltrate on chest X-ray associated with any two of the following clinical signs: body temperature >38°C, leucocytosis >12,000/ml or leukopenia <4000/ml, and purulent pulmonary secretions that were associated with a positive quantitative or semi-quantitative bacteriological culture of a respiratory tract sample.
|
28 days
|
|
Composite measure of compliance to guidelines
Periodo de tiempo: 28 days
|
defined as the total number of performed eligible measures divided by the total number of measures for which each patient was eligible
|
28 days
|
|
Empirical treatment failure
Periodo de tiempo: 28 days
|
Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically
|
28 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Antoine Roquilly, PH, CHU de Nantes
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
- RC17_0434
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. .