Hospital-acquired Pneumonia in Intensive Care Unit

Sepsis Clinical Trial

— PNEUMOCARE  

Official title:

Hospital Acquired and Ventilator Associated Pneumonia : Impact of the New French Guidelines on Patients Care and Outcomes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348579
• Other study ID #: RC17_0434
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Hospital Acquired Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated
• Sepsis
• Ventilator-Associated Pneumonia

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