- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Nantes, Frankrijk, 44093
- CHU de Nantes
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days
Exclusion Criteria:
- Community-acquired pneumonia, pregnant women, refusal to participate
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-Alleen
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Unit length of stay
Tijdsspanne: 28 days
|
Duration of ICU hospitalization Safety Issue: NA
|
28 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Intensive Care Unit free-days at day 28
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 28 days
|
Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically
|
28 days
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Antoine Roquilly, PH, CHU de Nantes
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RC17_0434
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .