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.

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

Study Overview

• Status: Completed
• Conditions: Pneumonia; Sepsis; Ventilator-Associated Pneumonia; Hospital Acquired Pneumonia
• Intervention / Treatment: Other: Guidelines publication and application; Other: Targeted experience feedback

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.

• Study Type: Observational
• Enrollment (Actual): 1850

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients hospitalized in intensive care units with a hospital stay greater than 72 hours and a GIs-II greater than or equal to 15.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Guidelines publication and application; 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.	Other: Guidelines publication and application; Passing recommendations on using the guidelines in the intensive care units; Other: 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
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.	Other: Guidelines publication and application; Passing recommendations on using the guidelines in the intensive care units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unit length of stay	Duration of ICU hospitalization Safety Issue: NA	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Empirical treatment failure	Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically	28 days

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Société Française d'Anesthésie et de Réanimation
• Investigators: Principal Investigator: Antoine Roquilly, PH, CHU de Nantes

Publications and helpful links

General Publications

• Roquilly A, Chanques G, Lasocki S, Foucrier A, Fermier B, De Courson H, Carrie C, Danguy des Deserts M, Gakuba C, Constantin JM, Lagarde K, Holleville M, Blidi S, Sossou A, Cailliez P, Monard C, Oudotte A, Mathieu C, Bourenne J, Isetta C, Perrigault PF, Lakhal K, Rouhani A, Asehnoune K, Guerci P, Tran Dinh A, Chousterman B, Cupaciu A, Dahyot-Fizelier C, Bellier R, Au Duong J, Mansour A, Morel J, Beauplet G, Vibet MA, Feuillet F, Sébille V, Leone M. Implementation of French Recommendations for the Prevention and the Treatment of Hospital-acquired Pneumonia: A Cluster-randomized Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1601-e1610. doi: 10.1093/cid/ciaa1441.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Pneumonia; Intensive care unit; Ventilator associated; Hospital acquired pneumonia; Guidelines
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: RC17_0434

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No