Mouth Odor as a Precision Care Indicator for Preventing Pneumonia Among Middle-aged and Older Adults With Oral Frailty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Clearance of pneumonia associated oral bacteria
研究概览
简要总结
This research plan aims to first collect data on the oral function and oral hygiene status of the elderly population in the community and to understand the normal model of oral frailty among the older adults in the community. Subsequently, a comparison will be made between the oral status of hospitalized patients and the community-dwelling elderly population. The goal is to verify whether oral odor can be used as an objective biological indicator following intervention.
详细描述
The first stage will aim to examine the relationships between the level of oral frailty and pneumonia-associated pathogens, as well as to establish a mouth odor database among community-dwelling people; The second stage will compare the differences of the level of oral frailty, pneumonia associated pathogens, and mouth odor between 144 middle-aged and older healthy people and 160 hospitalization patients. The third stage will confirm whether the mouth odor is an effective biological maker to show the changes of oral frailty, pneumonia-associated pathogens, and mouth odor after oral management rehabilitation.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 50 years old,
- •Alert and oriented,
- •With sufficient comprehension and cooperation,
- •Willing to participate in oral assessment.
排除标准
- •Patients who score below 5 on the General Practitioner Assessment of Cognition (GPCOG),
- •Patients with oral treatments such as oral cancer treatment,
- •Patients with oral treatments such as periodontal disease treatment.
结局指标
主要结局
Clearance of pneumonia associated oral bacteria
时间窗: 1-month after discharge day
The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
oral frailty measures (oral functions)
时间窗: 1-month after discharge day
The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the "ta" sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.
Oral odor
时间窗: 1-month after discharge day
A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.
次要结局
未报告次要终点
研究者
Chen, Yen-Chin
Vice Head Nurse and Clinical Assistant Professor
National Cheng-Kung University Hospital