Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of reflux events
研究概览
简要总结
Monitoring and quantification of reflux events in high risk critically ill inpatients and lower risk general medical/surgical inpatients, with comparison to relevant clinical variables.
详细描述
The investigators will conduct a pilot prospective cohort study of the incidence of reflux of gastric contents into the esophagus and the correlation with clinically evident aspiration events. The investigators will demonstrate that an esophageal multichannel pH/impedance probe can be used safely and effectively in an inpatient population to monitor reflux of acidic and non-acidic contents into the esophagus. The investigators will determine the frequency and severity of reflux events in a 24 hour period in two hospitalized patient populations: general medicine patients on the wards and critically ill patients in the intensive care unit. The investigators will then examine the relationship between the documented reflux events and clinically apparent aspiration events. The incidence of these silent reflux events in hospitalized patients is currently unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age greater than 18 years
- •Admitted to medical-surgical floor or medical intensive care unit
排除标准
- •Patients with contraindication to nasogastric tube placement (facial trauma, active epistaxis, abnormal nasopharyngeal or facial anatomy, esophageal stricture or injury, esophageal varices)
- •Patients requiring non-invasive positive pressure ventilation
- •Patients with uncontrolled vomiting
- •Patients with planned or anticipated airway or esophageal procedure within the 24-hour monitoring period
- •Patients not expected to survive for 24 hours or those receiving hospice/palliative care
研究组 & 干预措施
pH/impedance monitor
干预措施: pH/impedance monitor (Device)
结局指标
主要结局
Number of reflux events
时间窗: 24 hours
Summation of acid reflux events and non-acid reflux events over 24hr monitoring period measured by pH change and impedance change detected by the probe
次要结局
- Combined aspiration event endpoint(Duration of hospitalization, on average 14 days)
- Clinically apparent aspiration events(Duration of hospitalization, on average 14 days)
研究者
Joshua Fessel
Assistant Professor
Vanderbilt University