Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to clinical stability-respiration (CS-r)
研究概览
简要总结
Numerous elderly patients are suffering from aspiration pneumonia due to anatomical or functional predisposing factors including enteral tube feeding, swallowing difficulties, and gastroesophageal reflux disease (GERD). Previous studies have been demonstrated that continuous positive airway pressure (CPAP) is an acceptable means of managing chronic aspiration, atelectasis, and GERD. The purpose of this study is to determine whether nocturnal nasal CPAP is beneficial in patients with aspiration pneumonia and that it would contribute to the rapid clinical stability of aspiration pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Diagnosis of pneumonia: the presence of new pulmonary infiltration in dependent areas on chest radiographs at the time of hospitalization with at least one of the following
- •New or increased cough
- •Abnormal temperature (< 35.6℃ or > 37.8℃)
- •Abnormal serum leukocyte count (leukocytosis, left shift, or leukopenia)
- •Aspiration tendency or risk factors for frequent or large volume aspiration with at least one of the following
- •Altered mental status
- •Gastrointestinal disorder
- •Dysphagia or swallowing difficulties
- •Esophageal motility disorders
- •Tracheostomy state
- •Enteral tube feeding
- •Informed consent
排除标准
- •Severe hypercapnia (PaCO2 > 70mmHg)
- •Respiratory arrest requiring tracheal intubation
- •Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
- •Failure of more than two organs
- •Recent trauma or burns of the neck and face
- •Non- cooperation
- •Pregnancy
- •Withdrawal of consent
- •Refusal of treatment
结局指标
主要结局
Time to clinical stability-respiration (CS-r)
时间窗: up to 2 weeks
time to respiratory stabilization (respiratory rate ≤ 24/min and arterial oxygen saturation ≥ 90% or a partial pressure of oxygen ≥ 60mmHg on room air or usual requirement level)
次要结局
- Late clinical stability rate(7 days)
- Early clinical stability rate(3 days)
- Hospital length of stay(1 day (during hospital admission))
- Frequency of bronchoscopy for toileting(1 day (during hospital admission))
- Time to clinical stability(up to 2 weeks)
- In-hospital mortality(1 day (during hospital admission))
- Broadening of antimicrobial spectrum(1 day (during hospital admission))
- Radiological improvement(3 and 7 days)
研究者
Eun Sun Kim
Associate professor
Seoul National University Bundang Hospital