The Effect of Preoperative Inspiratory Muscle Training Using Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Atelectasis
研究概览
简要总结
The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications.
详细描述
Postoperative pulmonary complications (PPC) are the most common adverse events following lung resection, with a reported incidence of over 20-30% in some series. The objective of this study is to demonstrate that inspiratory muscle training (IMT) with daily use of an incentive spirometer (IS) for at least 14 days prior to lung surgery will reduce the risk of PPCs compared to the usual care, consisting of no formal preoperative IMT. The hypothesis is that preoperative inspiratory spirometer breathing (ISB) is a feasible and cost-effective intervention that can significantly reduce PPCs after lung resection. It is also hypothesized that patient compliance with the intervention will be high because of its simplicity, convenience, low cost and no potential for adverse effects.
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
- 是
入选标准
- •ECOG performance status score 2 or less
- •Undergoing elective lung resection (includes wedge resection, lobectomy, bi-lobectomy, pneumonectomy, sleeve resection) via minimally invasive (VATS or robotic) approach or thoracotomy
- •Chest wall resection if performed concurrently with lung resection
排除标准
- •ECOG performance status score greater than 2
- •Significant cognitive impairment preventing informed consent
- •Non-English speaking
- •Wedge biopsy for interstitial lung disease
- •Bullectomy for bullous emphysema
- •Pre-existing tracheostomy
- •Emergent or urgent surgery
- •Preoperative home oxygen use
- •History of neuromuscular disease
- •Prisoners
结局指标
主要结局
Atelectasis
时间窗: Through completion of follow-up (30 days)
Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist
Respiratory failure
时间窗: Through completion of follow-up (30 days)
Incidence of respiratory failure requiring re-intubation or high flow nasal cannula and/or non-invasive positive pressure ventilation
Pneumonia
时间窗: Through completion of follow-up (30 days)
Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy
Pneumothorax or subcutaneous emphysema
时间窗: Through completion of follow-up (30 days)
Incidence of clinically significant pneumothorax or subcutaneous emphysema requiring intervention or extended hospital admission for observation
Cardiac arrhythmia
时间窗: Through completion of follow-up (30 days)
Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)
Pleural effusion
时间窗: Through completion of follow-up (30 days)
Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics)
Prolonged air leak
时间窗: Through completion of follow-up (30 days)
Incidence of prolonged air leak (\>5 days) or requiring discharge with chest tube
Need for supplemental oxygen
时间窗: Through completion of follow-up (30 days)
Incidence of patients requiring supplemental oxygen upon discharge
Empyema/bronchopleural fistula
时间窗: Through completion of follow-up (30 days)
Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures
次要结局
- ICU length of stay(Through completion of follow-up (30 days))
- Change from baseline in dyspnea, measured by the modified Medical Research Council scale(Baseline, 2 weeks and 4 weeks after surgery)
- Hospital length of stay(Through completion of follow-up (30 days))
- Chest tube duration(Through completion of follow-up (30 days))
- Mortality(Through completion of follow-up (30 days))
- Hospital readmission(Through completion of follow-up (30 days))
研究者
Pauline Go
Associate Professor of Surgery
Milton S. Hershey Medical Center