- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03348579
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Nantes, 프랑스, 44093
- CHU de Nantes
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age > 18 years ; IGS-II score > 15 ; Hospital stay >= 3 days
Exclusion Criteria:
- Community-acquired pneumonia, pregnant women, refusal to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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Passing recommendations on using the guidelines in the intensive care units
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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. |
Passing recommendations on using the guidelines in the intensive care units
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
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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.
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Passing recommendations on using the guidelines in the intensive care units
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Unit length of stay
기간: 28 days
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Duration of ICU hospitalization Safety Issue: NA
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28 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intensive Care Unit free-days at day 28
기간: 28 days
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The number of days from day 1 to day 28 on which a patient is alive outside of intensive care unit Safety Issue
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28 days
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Hospital-acquired pneumonia
기간: 28 days
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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.
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28 days
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Composite measure of compliance to guidelines
기간: 28 days
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defined as the total number of performed eligible measures divided by the total number of measures for which each patient was eligible
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28 days
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Empirical treatment failure
기간: 28 days
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Defined as one or more pathogen involved in the pneumonia is not susceptible to the antibiotics used empirically
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28 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Antoine Roquilly, PH, CHU de Nantes
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Guidelines publication and application에 대한 임상 시험
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University of BirminghamNational Institute for Health Research, United Kingdom알려지지 않은