Feasibility of Inspiratory Muscle Training in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention and Complicated With High Risk of Pneumonia: a Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in inspiratory muscle strength
研究概览
简要总结
Pneumonia is uncommon high among patients with acute myocardial infarction (AMI), which increases adverse clinical events and prolongs the hospital stay. Inspiratory muscle training (IMT) is able to improve inspiratory muscle strength and prevent pneumonia in patients undergoing cardiac surgery including coronary artery bypass grafting. Thus, the investigators design the study mainly aim to evaluate the 30 days IMT for the change of inspiratory muscle strength, and also to observe its potentially effect on reducing pneumonia, in participants who accepted primary percutaneous coronary intervention (PCI) and at a high risk of pneumonia.
详细描述
This is a single center, prospective, randomized controlled study. All participants will be followed up until 30 days after randomized.
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
- •age ≥ 18 years, patients with AMI undergoing primary PCI, admitted to cardiac intensive care unit and at a high pneumonia risk [2 or more of the following parameters are regarded as high risk for pneumonia:
- •Age > 55 years,
- •Diabetes mellitus,
- •Smoking at present,
- •Chronic kidney disease: estimated glomerular filtration rate < 60 mL/min/1.73m2,
- •Forced expiratory volume in the first second of expiration (FEV1) < 80% predicted and FEV1/forced vital capacity (FVC) < 70% predicted]
- •be able to understand and agree with informed consent
排除标准
- •a history of cerebrovascular accident
- •treat with immunosuppressive medication for 30 days before
- •neuromuscular disorder
- •cardiovascular instability (such as aortic dissection or unstable hemodynamics)
- •a history of Coronary Artery Bypass Grafting (CABG)
- •expected survival is less than 6 months due to noncardiogenic disease
- •participated in other drugs and devices studies within 30 days
- •confirmed as ventricular aneurysm
- •other conditions not suit for the study after the discussion among the researchers (eg: poor compliance, unable to cooperate for the training)
结局指标
主要结局
Change in inspiratory muscle strength
时间窗: at baseline, at 30 days
Static maximal inspiratory pressure (MIP) will be selected for the estimation of inspiratory muscle strength. A standard measurement using Powerbreathe® K5 and according to "ERS Statement on Respiratory Muscle Testing at Rest and during Exercise" published by European Respiratory Society (ERS) will be taken (Laveneziana, 2019). MIP test will be performed at baseline and at 30 days.
次要结局
- Pneumonia(up to 30 days)
- Major adverse cardiovascular events (MACE)(up to 30 days)
- Vital signs of participants during training(up to 30 days)
- Satisfactory assessment(up to 30 days)
- Length of stay(up to 120 days)