Microbiological Evaluation of the Efficacy of Water to Clean Tracheostomy Inner Cannulas: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Efficacy of water vs detergent in cleaning tracheostomy inner cannulas
研究概览
简要总结
Biofilms pose a potential risk with reusable inner cannulas, by increasing the risk of infection. Effective decontamination is vital in eliminating these biofilms. An appropriate method of cleaning and decontamination to make inner cannula safe for reuse should be practiced. The current recommendations for cleaning inner cannula are varied with multiple techniques being put forth. The current practice of using sterile water to clean inner cannula is not supported by strong evidence. This Randomized Controlled Study looks into the microbiological efficacy of sterile water in cleaning inner cannulas.
详细描述
Tracheostomy Care of Patients:
The tracheostomy care of all patients included in the study will be the same as any other tracheostomy patient in the hospital, as directed by the tracheostomy care nursing policy. Before study procedure, inner cannula is to be checked to ensure it is not clogged with secretion, any secretion is to be removed with suction.
Decontamination methods:
Patients may fall under group A or group B as determined by the random allocation.
Patients in decontamination group A: Detergent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Eligible patients will be randomized in 1:1 fashion using permuted blocks with different block sizes. The subjects and lab operators will be blinded to the block size and randomization. In the event unmasking need to be performed, a staff who is not involved in this study from Clinical Trial Unit will perform the unmasking.
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients under the purview of the tracheostomy care team at Changi General Hospital will be considered for inclusion in the study.
- •Patients aged between 21 - 100 years
- •Patients with a tracheostomy tube in situ
排除标准
- •Pregnant women
- •Prisoners
- •Patients with documented HIV, Hep C, Hep B
- •Patients with active tuberculosis
- •Patients being treated in Intensive Care Units
- •Patients with ongoing antibiotic treatment or within the last 24 hours
- •Unstable patients needing cardiorespiratory support
结局指标
主要结局
Efficacy of water vs detergent in cleaning tracheostomy inner cannulas
时间窗: 1 week
Compare the colony forming units / ml before and after cleaning with water vs detergent
次要结局
- Economic evaluation(2 years)
- Microbiological evaluation(2 weeks)
研究者
Chan Hong Eng
Senior Nurse Clinician
Changi General Hospital