Effect of daily application of a 0.05% chlorhexidine solution on the incidence of (aspiration) pneumonia in care home residents: design of a multicentre cluster randomised controlled clinical trial.
Effect of daily application of a 0.05% chlorhexidine solution on the incidence of (aspiration) pneumonia in care home residents: design of a multicentre cluster randomised controlled clinical trial.
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DOI：
10.1136/bmjopen-2015-007889
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发表时间：
2015-12-29
期刊：
影响因子：
2.9
通讯作者：
de Baat C
中科院分区：
文献类型：
--
作者：
Hollaar V;van der Maarel-Wierink C;van der Putten GJ;de Swart B;de Baat C
肺炎是护理院居民死亡的重要原因。吞咽困难和口腔健康不良是发生吸入性肺炎的重要危险因素。口腔卫生护理可以减少口腔细菌的数量和吸入性肺炎的风险。然而，目前尚不清楚哪种口腔卫生护理干预措施在降低吸入性肺炎风险方面最有效。该研究的目的是评估除了常规的日常口腔卫生护理外，使用含有0.05%氯己定的溶液是否可以降低患有吞咽困难的肢体残疾护理院居民的肺炎发病率。该研究设计为多中心随机分组对照临床试验，以护理院为随机分组单位。在1年内，将对500名患有吞咽困难的身体残疾护理院居民进行随访。 干预包括在常规口腔卫生护理后立即每天两次使用含0.05%洗必泰的溶液，而对照组在常规口腔卫生护理后不使用。主要结果是由医生使用一套严格描述的标准诊断的肺炎发生率。将使用考克斯回归分析确定干预对肺炎发生率的影响。次要结局是肺炎发病率、年龄、性别、诊断疾病、吞咽困难严重程度、护理依赖性、实际使用的药物、牙齿和种植体数量以及可摘义齿存在之间的相关性。从Radboud大学医学中心医学伦理委员会获得伦理批准：NL.nr：41990.091.12。将获得所有参与护理院和居民的书面和知情同意。这项研究的结果将发表在同行评审的期刊上。该试验已在荷兰国家试验注册中心注册：TC=3515。
Pneumonia is an important cause of death in care home residents. Dysphagia and poor oral health are significant risk factors for developing aspiration pneumonia. Oral hygiene care reduces the number of oral bacteria and the risk of aspiration pneumonia. However, it is not clear yet which oral hygiene care intervention is most efficacious in reducing the risk of aspiration pneumonia. The aim of the study is to assess whether the application of a 0.05% chlorhexidine-containing solution in addition to the usual daily oral hygiene care reduces the incidence of pneumonia in physically disabled care home residents with dysphagia. The study was designed as a multicentre cluster randomised controlled clinical trial, with care homes as units of randomisation. During 1 year, 500 physically disabled care home residents with dysphagia will be followed. The intervention consists of applying a 0.05% chlorhexidine-containing solution twice daily, immediately after the usual oral hygiene care, whereas the control group receives no application after the usual oral hygiene care. The primary outcome is the incidence of pneumonia diagnosed by a physician, using a set of strictly described criteria. The effect of the intervention on the incidence of pneumonia will be determined using a Cox regression analysis. The secondary outcomes are correlations between incidence of pneumonia, age, gender, diagnosed diseases, dysphagia severity, care dependency, actually used medication, number of teeth and implants present and the presence of removable dentures. Ethical approval was obtained from the Medical Ethical Committee of Radboud university medical centre: NL.nr: 41990.091.12. Written and informed consent will be obtained from all participating care homes and residents. The study's findings will be published in peer-reviewed journals. The trial has been registered in the Netherlands in the National Trial Register: TC=3515.