Effects of Bilevel Positive Airway Pressure in Postoperative Cardiac Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Peripheral Oxygen Saturation by pulse oximetry
研究概览
简要总结
The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients undergoing cardiac surgery at the University Hospital of Santa Maria.
详细描述
This randomized controlled trial aimed to evaluate the effects of Bilevel Positive Airway Pressure (BiPAP) in patients undergoing heart surgery of valve replacement and coronary artery bypass graft on the variables clinics, cardiorespiratory and physical functional.These individuals were randomized to compose the control group (GC) and the BiPAP group (GBiPAP). The routine physical therapy was performed in both groups and in the BiPAPG two daily sessions of 20 minutes were applied with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O. To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: the 6-minute walk test (6MWT), the heart rate variability, the manovacuometry, and cirtometry in the axillary line, umbilical line and the xiphoid appendix.
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 (Investigator)
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
- •Hospitalized patients in preoperative for coronary artery bypass or valve replacement.
排除标准
- •Inability to understand or sign a free and informed consent form
- •Chronic obstructive pulmonary disease (COPD)
- •Cerebrovascular disease
- •Musculoskeletal disease
- •Chronic infectious disease
- •Unstable angina
- •Treatment with steroids, hormones or chemotherapy for cancer
- •Prolonged mechanical ventilation
- •Unable of maintaining airway patency
- •Severe hemodynamic instability
- •Abdominal distension or vomiting.
结局指标
主要结局
Peripheral Oxygen Saturation by pulse oximetry
时间窗: up to 36 weeks
次要结局
- Length of stay(up to 36 weeks)
- Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)(up to 36 weeks)
- Vital Signs(up to 36 weeks)
- Six-minute walk test (6MWT)(up to 36 weeks)
- Heart rate variability by a pulse frequency meter(up to 36 weeks)
- Postoperative complications(up to 36 weeks)
- Maximum expiratory pressure by a digital pressure transducer (manovacuometry)(up to 36 weeks)
研究者
Prof. Dr. Antônio Marcos Vargas da Silva
PhD in Physiology
Universidade Federal de Santa Maria