Nebulized Hypertonic Saline for Inpatient Use in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- OhioHealth
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale
研究概览
简要总结
A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale scores after 4 treatments within 24 hours.
详细描述
Hypothesis:
A clinically significant difference exists between albuterol treatments with nebulized 3% saline versus standard saline, for improvements in the patient's modified Borg dyspnea score during an acute exacerbation of COPD.Study
Population:
This study will involve 146 patients admitted to Doctors Hospital in Columbus, Ohio from September 2014 through September 2015 with a clinical diagnosis of an acute exacerbation of COPD, defined as an increase in the patient's dyspnea, cough, or change in sputum consistency/volume/color from the patient's baseline during stable conditions.
Study Design:
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
- •Patients at least 18 years of age
- •Admitted to Doctors Hospital with a clinical diagnosis of COPD
- •Documented obstruction on spirometry from prior records available at the time of the study.
排除标准
- •Patients younger than 18 years of age
- •Spirometry data not available
- •History of smoking less than twenty pack-years
- •Possibility of other primary cause of the patient's change in dyspnea or cough (e.g. pneumonia, congestive heart failure with pulmonary edema, myocardial infarction)
- •Patient is found to have a different primary cause after initial enrollment
- •Non-English speaking subjects
研究组 & 干预措施
Hypertonic Saline
Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).
Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.
干预措施: hypertonic saline (Drug)
Standard Saline
Patients will receive standard saline (0.9%) saline along with standard 2.5 mg. albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).
Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.
干预措施: standard saline (Drug)
结局指标
主要结局
Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale
时间窗: Pre-treatment (baseline) vs. 24 hours post-treatment
This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein "0" indicates no difficulty breathing, and "10" indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates "very, very slight (just noticeable) difficulty in breathing." A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing.
次要结局
- 30 Day Readmission(30 days post discharge)
- 30 Day All Cause Mortality(30 days post discharge)