Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- St. George's Respiratory Questionnaire
研究概览
简要总结
Airway stents are used as standard of care to identify which patients with excessive dynamic airway collapse will benefit from a definitive surgical treatment. However, the specific way in which these stents are effective has not been tested. The purpose of this research study is to determine the effectiveness of airway stents when used in the airways of patients with severe symptomatic excessive dynamic airway collapse compared to patients with severe symptomatic excessive dynamic airway collapse that do not receive airway stent.
详细描述
Study Design
This randomized controlled trial will be conducted at Beth Israel Deaconess Medical Center (BIDMC) in accordance with Good Clinical Practice Standards and under IRB supervision. We plan to enroll total of 48 patients with EDAC randomized by a computer generated system to either intervention group (airway stent) or medical management group.
Description of the study
Previous to appointment all patients will have Airway CT scan, 6 minute walk test and pulmonary function test as per protocol and standard of care.
Enrollment
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
- 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
- •Patient with sever symptomatic EDAC (collapse >90% of the airway during exhalation at dynamic CT scan)
- •Age > 18 years
排除标准
- •Patients who have not been well managed from their respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis)
- •Current respiratory infection
- •Resting bradycardia (<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
- •Dysrhythmia that might pose a risk during exercise or training
- •Any disease or condition that interferes with completion of initial or follow-up assessments
研究组 & 干预措施
Medical Management Group
The patients assigned to the medical management group will be placed on a scheduled institution protocol using mucolytic and expectorant therapy (nebulizer treatments using mucolytic (N-acetylcysteine) for 15 minutes BID, Guafenesin (Mucinex®) 1200 mg BID, codeine as needed and Flutter valve BID.
Treatment group
The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
干预措施: Dynamic Flexible Bronchoscopy (Procedure)
Treatment group
The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
干预措施: Rigid Bronchoscopy (Procedure)
Treatment group
The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
干预措施: Stent placement (Device)
结局指标
主要结局
St. George's Respiratory Questionnaire
时间窗: 7-14 days
Index designed to measure health status in patients with respiratory symptoms
次要结局
- Complications(7-14 days)
- 6 minute walk test(7-14 days)
- FEV1(7-14 days)
- Cough Quality of life Questionnaire(7-14 days)
- Peak flow(7-14 days)
- Self-reported symptoms(7-14 days)
- modified Medical Research Council scale of dyspnea(7-14 days)
研究者
Adnan Majid, MD
MD
Beth Israel Deaconess Medical Center