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Hospital-acquired Pneumonia in Intensive Care Unit (PNEUMOCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348579
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Société Française d'Anesthésie et de Réanimation
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Hospital Acquired Pneumonia Ventilator-Associated Pneumonia Sepsis Pneumonia 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1850 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Hospital Acquired and Ventilator Associated Pneumonia : Impact of the New French Guidelines on Patients Care and Outcomes.
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Unit length of stay [ Time Frame: 28 days ]
    Duration of ICU hospitalization Safety Issue: NA


Secondary Outcome Measures :
  1. Intensive Care Unit free-days at day 28 [ Time Frame: 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

  2. Hospital-acquired pneumonia [ Time Frame: 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.

  3. Composite measure of compliance to guidelines [ Time Frame: 28 days ]
    defined as the total number of performed eligible measures divided by the total number of measures for which each patient was eligible

  4. Empirical treatment failure [ Time Frame: 28 days ]
    Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348579


Locations
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France
CHU de NANTES
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Société Française d'Anesthésie et de Réanimation
Investigators
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Principal Investigator: Antoine Roquilly, PH CHU DE NANTES
Principal Investigator: Marc Leone AP-HM

Additional Information:

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03348579    
Other Study ID Numbers: RC17_0434
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Intensive care unit
Pneumonia
Ventilator associated
Hospital acquired pneumonia
Guidelines
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes