Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Rate of Bronchospiration pneumonia among study participants during their ICU admission
研究概览
简要总结
Patients of age >18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups:
- Patients admitted to the ICU in the first 3-4 months will have their bed head elevated to 15 degrees + H2 blockers administration + mouth wash BID
- Patients admitted to the ICU in the following 3-4 months will have their bed head elevated to 30 degrees + H2 blockers administration + mouth wash BID
- Patients admitted in the last 3-4 months will have their bed head elevated to 45 degrees + H2 blockers administration + mouth wash BID.
All patients will have their vital signs, BMI, and fluids ins and outs measured every 24 hours until the discharge from the ICU or death. All patients will be evaluated for GI functions (no vomiting, flatus+, bowel movement +, bowel sounds+, and KUB with normal gas distribution pattern) prior to oral intake.
Patients in the three groups will be matched by age, sex, and BMI with historical controls with broncho- aspiration (BA) (positive controls) and without BA events (negative controls) from a pool of 20,032 ICU admissions (01JAN2010 to 31DEC2019).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients admitted to ICU by surgery department.
- •Development of aspiration pneumonia in patients admitted to ICU department of VA hospital.
- •Aspiration Pneumonia development during hospital stay and treating physician indicated the diagnosis of aspiration pneumonia in history and physical exam notes.
排除标准
- •Patient transferred or admitted to the hospital as a primary diagnosis of aspiration pneumonia (development of aspiration pneumonia prior to admission).
- •Treating physician not documented aspiration pneumonia in history or physical exam notes.
- •Drug overdose, seizure or cardiopulmonary arrest prior to hospital admission.
结局指标
主要结局
Rate of Bronchospiration pneumonia among study participants during their ICU admission
时间窗: 12 Months
Calculating the number of subjects who developed bronchoaspiration pneumonia compared to the total number of ICU admission
次要结局
- Determine if there is an association between BA events and death rate in the ICU for the specified time period(12 Months)
研究者
Juan Sanabria
Professor of Surgery, Vice-Chair & Scientific Director
Marshall University