跳至主要内容
临床试验/NCT03279887
NCT03279887已完成不适用

Usefulness of Lung Ultrasonography for Diagnosis of Pneumonia After Major Cardiac Surgery: a Pilot Study

Groupe Hospitalier Pitie-Salpetriere0 个研究点目标入组 51 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
主要终点
Final diagnosis of pneumonia

研究概览

简要总结

Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia, but its usefulness and reliability was never evaluated after cardiac surgery. This study investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiac surgery with sternotomy and cardio-pulmonary bypass (CPB) less than 3 days before
  • At least one component suggestive of ARF:
  • If mechanical ventilation, a PaO2 / FiO2 ratio <200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation,
  • If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea> 25/min, upper or intercostal swallowing, abdominal swing ...), SpO2 < 90% or PaO2 <60 mmHg despite oxygen therapy ≥ 3L/min.

排除标准

  • Minor patients
  • Pregnancy
  • Sleep apnea syndrome
  • Participation refusal

结局指标

主要结局

Final diagnosis of pneumonia

时间窗: During the 72 hours following surgery

Pneumonia or excluded pneumonia, was determined by consensus of 3 investigators, after an independent post hoc review of the medical records. Pneumonia diagnosis was based on concordance of clinical and radiological criteria (≥ 2 criteria including fever\> 38.5 ° C or T \<36 ° C, leukocytosis\> 10 \^ 9 / L or leukopenia \<4.10 \^ 8 / L, purulent tracheal secretions and the appearance or persistence of an infiltrate on the CXR). It should be confirmed by culture of a respiratory specimen: protected distal sampling with a threshold of significance ≥ 10 \^ 3 colony forming unit/mL or bronchoalveolar lavage with a threshold of significance ≥ 10 \^ 4 CFU/mL.

次要结局

未报告次要终点

研究者

发起方
Groupe Hospitalier Pitie-Salpetriere
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrien Bouglé

Principal Investigator

Groupe Hospitalier Pitie-Salpetriere

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