Comparison of Foam Swabs Versus Toothbrushes in Removing Dental Plaque From Orally Intubated Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Modified Silness and Loe plaque and gingival index following cleaning of teeth
研究概览
简要总结
Cleaning the mouth is difficult in critically ill patients who require support from a breathing machine (ventilator). This is because the plastic (endotracheal) tube which is a necessary interface between patient and ventilator impedes cleaning. New evidence suggests that poor oral health may be linked to ventilator associated pneumonia. Throughout the world both toothbrushes and foam swabs are used to clean the teeth and remove dental plaque, however it is unknown if one method is more effective than the other. The purpose of this study is to establish which (if any) method is most effective at removing plaque in this population of patients.
详细描述
Study Objective: The principle aim of this work is to determine whether foam swabs or toothbrushes offer the most effective method of removing dental plaque in orally intubated mechanically ventilated patients.
The secondary objective is to profile the microbiological flora in dental plaque, endotracheal tube and lung. In addition, collection of both plaque samples, used endotracheal tubes (ETTs) and non-directed bronchoalveolar lavage (NBL) will allow us to determine whether oral microorganisms contribute to biofilm formation within the ETT and potentially promote VAP. The findings of this study will not only enhance our knowledge on the organisms involved in promoting biofilms on ETT, but may also highlight potential management strategies to reduce their formation.
Study Population: Critically ill adult patients admitted to the intensive care unit at the University Hospital of Wales, Cardiff in whom mechanical ventilation has been initiated.
Recruitment: All patients satisfying inclusion and exclusion criteria, admitted to the adult ICU at the University Hospital of Wales from the start date of the study will be considered eligible for recruitment. Patients identified by the duty consultant will be notified to the research team. Consent will be obtained and in total 50 patients will be recruited.
Interventions: This is a split mouth design study whereby the intervention (cleaning with a foam swab or toothbrush) is performed on one side of the mouth. For example foam swab left side of mouth and toothbrush right side of mouth. Cleaning will be performed daily for a minimum of 24-hours or until extubation or up to seven days after recruitment, whichever is the shorter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years
- •Patients mechanically ventilated with an oral endotracheal tube ->20 teeth with symmetric distribution
排除标准
- •Absence of an oral endotracheal tube
- •Age <18 years
- •<20 teeth or asymmetric distribution
- •Expected to be intubated less than 24-hours from recruitment
- •Thrombocytopaenia (platelet count <30)
- •Uncontrolled coagulopathy
- •Suffering from facial or oral trauma
结局指标
主要结局
Modified Silness and Loe plaque and gingival index following cleaning of teeth
时间窗: Daily until day seven
The Silness and Loe plaque and gingival index scores plaque and gum disease as 0,1,2, or 3 for each tooth. The index is derived by adding scores and dividing by the number of teeth examined (maximum score 3, minimum 0). The index will be compared between teeth cleaned with a toothbrush versus those cleaned with a swab
次要结局
- Quantitative comparisons of bacterial counts following the two cleaning methods(Daily until day seven)