- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
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Nantes, França, 44093
- CHU de NANTES
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days
Exclusion Criteria:
- Community-acquired pneumonia, pregnant women, refusal to participate
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Caso-somente
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Unit length of stay
Prazo: 28 days
|
Duration of ICU hospitalization Safety Issue: NA
|
28 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intensive Care Unit free-days at day 28
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 28 days
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Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically
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28 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Antoine Roquilly, PH, CHU de NANTES
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RC17_0434
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