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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Nantes, Frankreich, 44093
- Chu de Nantes
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days
Exclusion Criteria:
- Community-acquired pneumonia, pregnant women, refusal to participate
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Nur Fall
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Unit length of stay
Zeitfenster: 28 days
|
Duration of ICU hospitalization Safety Issue: NA
|
28 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Intensive Care Unit free-days at day 28
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 28 days
|
Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically
|
28 days
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Antoine Roquilly, PH, Chu de Nantes
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RC17_0434
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .