The Effect of Preoperative Inspiratory Muscle Training Using Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Respiratory Complication
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Atelectasis
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Pauline Go
Associate Professor of Surgery
Milton S. Hershey Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Atelectasis
Time Frame: Through completion of follow-up (30 days)
Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist
Respiratory failure
Time Frame: 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
Time Frame: Through completion of follow-up (30 days)
Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy
Pneumothorax or subcutaneous emphysema
Time Frame: 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
Time Frame: Through completion of follow-up (30 days)
Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)
Pleural effusion
Time Frame: 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
Time Frame: Through completion of follow-up (30 days)
Incidence of prolonged air leak (\>5 days) or requiring discharge with chest tube
Need for supplemental oxygen
Time Frame: Through completion of follow-up (30 days)
Incidence of patients requiring supplemental oxygen upon discharge
Empyema/bronchopleural fistula
Time Frame: Through completion of follow-up (30 days)
Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures
Secondary Outcomes
- 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))