Hospital-acquired Pneumonia in Intensive Care Unit

Completed

• Conditions: Hospital Acquired Pneumonia; Ventilator-Associated Pneumonia; Sepsis; Pneumonia
• Interventions: Other: Guidelines publication and application; Other: Targeted experience feedback

• Registration Number: NCT03348579
• Lead Sponsor: Nantes University Hospital

Brief 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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-15
• Status Verified: 2017-11
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Primary Completion: 2018-10-15
• Study Completion: 2018-12-15
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1850

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The second period	Targeted experience feedback	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.
The third and final period	Guidelines publication and application	The third and final period will consist of all consecutive patients admitted to the participating ICUs after the formal training.
The before period	Guidelines publication and application	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.
The second period	Guidelines publication and application	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.

Primary Outcome Measures

Name	Time	Method
Unit length of stay	28 days	Duration of ICU hospitalization Safety Issue: NA

Secondary Outcome Measures

Name	Time	Method
Intensive Care Unit free-days at day 28	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
Hospital-acquired pneumonia	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.
Composite measure of compliance to guidelines	28 days	defined as the total number of performed eligible measures divided by the total number of measures for which each patient was eligible
Empirical treatment failure	28 days	Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically

Trial Locations

Locations (1)

CHU de NANTES; 🇫🇷 Nantes, France