Expiratory Positive Pressure With Blow-bottle Device Versus Expiratory Positive Airway Pressure (EPAP) in Patients After Postoperative Cardiac Surgery: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Pulmonary function - forced expiratory volume in the first second
研究概览
简要总结
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients through a randomized clinical trial. Methods: The study was approved by the Research Ethics Committee of the Hospital de Clínicas of Porto Alegre (CAEE: 70213617.6.0000.5327). Patients undergoing cardiac surgery were randomized into three groups: positive expiratory pressure with blow-bottle device associated with conventional physiotherapy (G1), positive expiratory pressure in the airways with unidirectional valve associated with conventional physiotherapy (G2), and the third group only the conventional physiotherapy of HCPA cardiac intensive care unit (G3). Initially, an evaluation was performed through spirometry, manovacuometry, radiological changes in the preoperative period, prior to the interventions (immediate postoperative) and on the third postoperative day, immediately prior to cardiac intensive care unit discharge. Pulmonary complications were assessed on the third postoperative day, and length of stay (at the Intensive Care Unit and hospital) were recorded untill discharge.
详细描述
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients. Methods:This is a randomized clinical trial, with patients in postoperative cardiac surgery. On the first day of postoperative, the patients will be randomized into three groups: 1 group that will receive positive expiratory pressure with blow-bottle device associated with conventional physiotherapy; 2- group that will receive positive expiratory pressure in the airways with valve unidirectional therapy associated with conventional physiotherapy; 3- group that will only receive conventional physiotherapy. The intervention of the positive expiratory pressure with blow-bottle device group will consist of exercise with a blow-bottle device of 10 cm high; the positive expiratory pressure in the airways group, exercise with unidirectional positive expiratory pressure valve (10cmH2O). Both the groups will perform three sets of 10 repetitions per day, by the third day of PO. The third group will receive conventional physiotherapy of intensive care unit. The outcomes evaluated will be: pulmonary function (primary), respiratory muscle strength, pulmonary complications, radiological changes and length of stay (at the Intensive CareUnit - ICU - and hospital). Assessment of pulmonary function, muscle strength and radiological changes will be performed in the preoperative period, prior to the interventions and on the third postoperative day, immediately prior to discharge of cardiac intensive care unit. Pulmonary complications and ICU length of stay will be recorded after discharge from intensive care unit cardiac. The length of hospital stay was recorded after hospital discharge.
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 (Outcomes Assessor)
盲法说明
Double blind: allocation concealment and outcome assessor
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
- •Elective cardiovascular surgery of:
- •coronary artery bypass graft surgery alone
- •coronary artery bypass graft surgery combined with aortic valve surgery
- •coronary artery bypass graft surgery combined with bicuspid valve surgery
- •coronary artery bypass graft surgery combined with tricuspid valve surgery
- •Aortic valve surgery
- •Bicuspid valve surgery
- •Tricuspid valve surgery
- •All on spontaneous ventilation or with supplemental oxygen support.
排除标准
- •Patients with hemodynamic instability (heart rate> 120bpm, clinically important hypotension - vasopressor dose ≥ 0.1mcg / kg / min)
- •Cardiac arrhythmia
- •Heart transplantation
- •Angina at rest and/or minor efforts
- •Mechanical ventilation for more than 24 hours
- •Re-hospitalized patients with decompensated heart failure
- •Noninvasive mechanical ventilation
- •Non-collaborative and with cognitive inability to understand the procedures
- •Reintubated patients
- •Re-operated patients
- •In order to perform the pulmonary function test, patients may not present the following contraindications:
- •recent angina
- •retinal detachment
- •hypertensive crisis
- •pulmonary edema
- •thoracic aortic aneurysm
- •In order to perform the respiratory muscle strength test, patients may not present the following contraindications:
- •acute myocardial infarction
- •recent unstable angina
- •severe and uncontrolled systemic arterial hypertension
- •aortic aneurysm
- •pneumothorax
- •pleurocutaneous or pulmonary fistulas
- •surgery or recent trauma to the upper airways, chest or abdomen
- •abdominal hernia
- •acute middle ear problems
- •glaucoma or retinal detachment
- •hydrocephalus
- •meningocele
- •neurological processes that favor the choking of tonsils
- •general state of physical or mental impairment that impedes the patient's collaboration.
结局指标
主要结局
Pulmonary function - forced expiratory volume in the first second
时间窗: three days
Pulmonary function through spirometry, that allows to measure forced expiratory volume in the first second. It's the maximum expired volume at the first second of an maximum expiration .
Pulmonary function - forced vital capacity
时间窗: three days
Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum.
Pulmonary function - the ratio: forced expiratory volume in the first second / forced vital capacity
时间窗: three days
Pulmonary function through spirometry, obtained through forced maneuver (forced vital capacity) and forced expiratory volume in the first second - represents the maximum expired volume at the first second of an maximum expiration.
次要结局
- Pulmonary complications - atelectasis(three days)
- Pulmonary complications - pleural effusion(three days)
- Pulmonary complications - pneumothorax(three days)
- Pulmonary complications - pneumonia(three days)
- Pulmonary complications - respiratory infection(three days)
- Radiological changes - pneumothorax(three days)
- Radiological changes - pulmonary edema(three days)
- Respiratory muscle strength - maximal inspiratory pressure(three days)
- Pulmonary complications - respiratory failure(three days)
- Radiological changes - atelectasis(three days)
- Radiological changes - consolidation(three days)
- Length of Intensive Care Unit (ICU) stay(three days)
- Respiratory muscle strength - maximum expiratory pressure(three days)
- Radiological changes - pleural effusion(three days)
- Length of hospital stay(up to 25 days)