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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03348579
Other study ID # RC17_0434
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2017
Est. completion date December 15, 2018

Study information

Verified date November 2017
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

hospital-acquired pneumonia are a common disease in intensive care unit. The prevention, the diagnosis and the treatment of hospital acquired pneumonia are a frequent challenge. Nevertheless it seems that there are great differences in standard of care between hospitals. The investigators hypothesized that medical education and implementation of evidence-base guidelines can reduce the duration of mechanical ventilation in patients presenting of hospital acquired pneumonia


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 1850
Est. completion date December 15, 2018
Est. primary completion date October 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days

Exclusion Criteria:

- Community-acquired pneumonia, pregnant women, refusal to participate

Study Design


Intervention

Other:
Guidelines publication and application
Passing recommendations on using the guidelines in the intensive care units
Targeted experience feedback
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

Locations

Country Name City State
France CHU de NANTES Nantes

Sponsors (2)

Lead Sponsor Collaborator
Nantes University Hospital Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unit length of stay Duration of ICU hospitalization Safety Issue: NA 28 days
Secondary Intensive Care Unit free-days at day 28 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
Secondary Hospital-acquired pneumonia 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
Secondary Composite measure of compliance to guidelines defined as the total number of performed eligible measures divided by the total number of measures for which each patient was eligible 28 days
Secondary Empirical treatment failure Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically 28 days
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