A Randomized Study Evaluating Patients Discharged With Indwelling Chest Tube and Valve
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Change in empyema in patient's discharging with an indwelling chest tube and valve.
研究概览
简要总结
This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.
详细描述
This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be screened prior to discharging from the hospital and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained the subject will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. The subject will be followed until they have their chest tube removed.
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
- •≥ 18 years of age
- •Male and Female
- •Consultation with a thoracic surgeon
- •Discharge from the hospital with a chest tube and valve in place
- •Subject is able to understand the study procedures and provide informed consent.
排除标准
- •Pregnancy
- •Allergy to Keflex and Clindamycin
- •Special consideration should be taken in enrolling subjects with preexisting conditions that can be exacerbated by antibiotic use but are allowed at the discretion of the treating physician.
结局指标
主要结局
Change in empyema in patient's discharging with an indwelling chest tube and valve.
时间窗: 30 days post discharge
The proportion of patients having 30-day empyema in the two treatment arms will be estimated and reported.
次要结局
- Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve.(30 days post discharge)
研究者
K Robert Shen
Principal Investigator
Mayo Clinic