The Effect of an Suction Toothbrush in Intubated Intensive Care Patients on the Development of Ventilator-Associated Pneumonia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The ventilatory associated pneumonia (VAP)
研究概览
简要总结
Literature suggests that suction toothbrushes may improve oral care in intubated patients by facilitating secretion removal and reducing microaspiration. This could decrease the need for endotracheal suctioning and lower the risk of ventilator-associated pneumonia (VAP). Therefore, this study aimed to examine the effect of a suction toothbrush on the development of VAP in intubated patients.
详细描述
in the literature examining the superiority of a suction toothbrush over another regarding the frequency of oral care practices, appropriate solution and material use in intubated patients. It is believed that a suction toothbrush will both facilitate oral care and clear oral secretions. By minimizing secretion accumulation in the mouth, it will prevent microaspiration and reduce the need for endotracheal suctioning in patients. Determining the most effective oral care method is expected to reduce the incidence of ventilator-associated pneumonia and positively impact patient mortality. Considering all this information, the aim of this study was to examine the effect of a suction toothbrush on the development of ventilator-associated pneumonia in intubated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •who aged over 18 years
- •who underwent orotracheal intubation after admission to the ICU,
- •who had no known pneumonia or diagnosis of pneumonia at the time of intubation,
- •who were intubated for more than 48 hours,
- •who had no microorganisms detected in the tracheal aspirate within the first 48 hours,
- •who had no lesions on the oral mucous membrane before intubation,
- •who had no known allergy to chlorhexidine were included in the study.
排除标准
- •who under 18 years of age,
- •those with a tracheostomy,
- •those were intubated for less than 48 hours,
- •those with microorganisms detected in their tracheal aspirate within the first 48 hours,
- •those who underwent reintubation,
- •those were pregnant,
- •those with lesions in the oral mucosa during intensive care admission,
- •those with bleeding coagulation disorders or thrombocytopenia,
- •those admitted to intensive care from an external institution while intubated, and those with a known chlorhexidine allergy were excluded from the study.
研究组 & 干预措施
Suction tootbrush + distilled water
All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions.
干预措施: Suction tootbrush and distiled water (Other)
Suction toothbrush + 0.12% chlorhexidine gluconate oral solution
Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care.
干预措施: suction tootbrush and .12% chlorhexidine gluconate (Other)
oral care sponge + 0.12% chlorhexidine gluconate oral solution
All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) with an oral care sponge used in oral care.
干预措施: Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution (Other)
结局指标
主要结局
The ventilatory associated pneumonia (VAP)
时间窗: Patients were included 48 hours after admission to the intensive care unit and intubation. After 48 hours of intubation, the development of VAP will be considered as a positive.
The development of ventilator-associated pneumonia (VAP) after entubation in the intensive care unit (Yes / no). If a patient presents signs and symptoms of VAP with both clinical Findings and laboratory findings, researchers will diagnose it as a VAP.
次要结局
未报告次要终点
研究者
Ayda Kebapci
Assoc Prof
Koç University