跳至主要内容
临床试验/NCT03871985
NCT03871985Unknown不适用

Efficacy of Intermittent Subglottic Secretion Lavage Combined With Aspiration Preventing Ventilator Associated Pneumonia in Patients With Severe Neurological Disease:A Single-center Randomized Controlled Trial

The First Hospital of Jilin University0 个研究点目标入组 234 人开始时间: 2019年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
234
主要终点
Incidence of ventilator-associated pneumonia

研究概览

简要总结

The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease

详细描述

Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)

排除标准

  • Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and

研究组 & 干预措施

Lavage combined with aspiration

Experimental

Intermittent subglottic secretions lavage combined with aspiration

干预措施: Subglottic secretion lavage combined with aspiration (Procedure)

Pure aspiration

Active Comparator

Intermittent subglottic secretions aspiration

干预措施: Subglottic secretion aspiration (Procedure)

结局指标

主要结局

Incidence of ventilator-associated pneumonia

时间窗: through study completion, an average of 10 months

is pneumonia that occurs when an artificial airway is established and mechanically ventilated

次要结局

  • Incidence of draining duct blockage(through study completion, an average of 10 months)

研究者

申办方类型
Other
责任方
Sponsor

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