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临床试验/NCT01613365
NCT01613365已完成3 期

Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 474 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
474
试验地点
1
主要终点
proportion of patients requiring ventilatory support

研究概览

简要总结

Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.

Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Adult men and women over 18 years
  • Submitted to major pulmonary resections for primary lung cancer or pulmonary metastasis
  • Anatomical resections (segmentectomy, lobectomy, pneumonectomy)
  • With mediastinal lymph node dissection.
  • Patient fit for operation
  • After informed consent
  • Non inclusion criteria:
  • Patients < 18 years
  • Pulmonary infectious lesions
  • Recent respiratory infections
  • Tracheostomy
  • Swallow difficulties
  • Need for non-invasive ventilation before surgery
  • Documented sensibility to Chlorhexidine
  • Previous ENT cancer
  • Previous thoracic surgery
  • Patients with an oral assessment score (OAG) >9

排除标准

  • 未提供

研究组 & 干预措施

chlorhexidine gluconate

Experimental

干预措施: Chlorhexidine Gluconate (Drug)

placebo

Experimental

干预措施: Placebo (Drug)

结局指标

主要结局

proportion of patients requiring ventilatory support

时间窗: 36 MONTHS

次要结局

  • occurrence of documented hospital-acquired respiratory infections(36 MONTHS)
  • occurrence of documented non-respiratory hospital-acquired infections(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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