Oscillatory Positive Expiratory Pressure Devices in Acute Inpatient Treatment of Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to evaluate oscillatory positive expiratory pressure (OPEP) devices for "airway clearance" (helping to clear out phlegm or mucous from your lungs and bronchial tubes) in the treatment of patients admitted to the hospital with pneumonia.
Approximately 200 subjects are expected to participate in this study.
详细描述
Pneumonia is one of the most common health conditions leading to hospitalization today. Approximately 1.3 million people in the US are admitted to the hospital with community-acquired pneumonia (CAP) annually, with readmission rates within the first 30 days as high as 20%. In a retrospective analysis of patients with culture-confirmed bacterial pneumonia, 30-day readmission occurred in 19.3% of patients. At Norwalk Hospital, the 30-day readmission rate for patients with pneumonia is 13.1%. CAP is the sixth most common cause of death with a case-fatality rate of up to 16% for hospitalized CAP patients, and an overall 30-day mortality up to 23%. The economic burden of CAP is also high, l with a CAP cost burden estimated to be at least $13 billion in 2008 within just the Medicare population.
There have been several small studies done to analyze the utility of airway clearance and its potential role in CAP. These studies have generally been small and have used a wide variety of airway clearance devices and techniques, including external chest wall physiotherapy devices and postural drainage, both now considered second line therapies for most patients. These studies have been variable in their findings and overall have not shown that airway clearance is either beneficial or harmful in CAP. The studies did show, however, that the duration of fever and hospital length of stay were both significantly decreased, suggesting the possibility of other clinically important benefits.
In this prospective randomized controlled trial, investigators will test the hypothesis that the use of OPEP devices, specifically the handheld Aerobika (Monaghan Medical) will result in more rapid and durable recovery in patients hospitalized with community-acquired pneumonia as measured by decreased hospital length of stay, reduced duration of fever, improvement in dyspnea, decreased duration of antibiotics, increased rate of diagnosis of the etiologic organism responsible for the pneumonia, and reduced readmission rates:
Primary outcome
- Reduction in hospital length of stay
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 (Participant)
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
- •Clinical symptoms suggesting pneumonia (eg. cough, fever, pleuritic chest pain, sputum production, dyspnea)
- •Any new chest radiographic infiltrate consistent with pneumonia
排除标准
- •Untreated or recently (within the past 90 days) treated pneumothorax
- •Active hemoptysis
- •Recent facial, oral, or skull trauma
- •Hemodynamically unstable patients
- •Severe nausea or active vomiting
- •Recent diagnosis of pneumonia prior to current inpatient encounter (within 60 days)
- •Significant cognitive impairment or psychiatric conditions that prevent ability to participate in or cooperate with oPEP use
- •Active TB or in negative pressure room
- •Pregnancy
- •Pre-existing medical condition with a life expectancy of less than 3 months
- •Inability to form appropriate mouth seal on device (eg. due to neuromuscular disease)
- •Pre-existing active use of oPEP devices
- •Requiring >=50% FiO2 or facemask (excluding high flow NC)
结局指标
主要结局
Length of Hospital Stay
时间窗: duration of hospital stay, an expected average of 4 days
Number of days that the patient stays in hospital was collected from medical record. We have calculated the mean and the standard deviation for both groups.
次要结局
- Reported 30-, 60-, and 90-day Readmission Rates(90 day after the hospital discharge)
- Number of Participants With Need for Oxygen Supplement at Hospital Discharge(duration of hospital stay, an expected average of 4 days)
- Duration of Fever(duration of hospital stay, an expected average of 4 days)
- Number of Participants Transferred to the Intensive Care Unit (ICU)(duration of hospital stay, an expected average of 4 days)
- Reported Dyspnea by Modified-Borg Score(duration of hospital stay, an expected average of 4 days)
- Duration of Antibiotics(duration of hospital stay, an expected average of 4 days)
- Number of Participants With Positive Sputum Culture(duration of hospital stay, an expected average of 4 days)