Effect of Preoperative Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
- Conditions
- Postoperative Respiratory Complication
- Interventions
- Other: Inspiratory muscle training
- Registration Number
- NCT04732143
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Incentive Spirometry Inspiratory muscle training Participants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery.
- Primary Outcome Measures
Name Time Method Atelectasis Through completion of follow-up (30 days) Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist
Respiratory failure 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 Through completion of follow-up (30 days) Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy
Pneumothorax or subcutaneous emphysema 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 Through completion of follow-up (30 days) Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)
Pleural effusion 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 Through completion of follow-up (30 days) Incidence of prolonged air leak (\>5 days) or requiring discharge with chest tube
Need for supplemental oxygen Through completion of follow-up (30 days) Incidence of patients requiring supplemental oxygen upon discharge
Empyema/bronchopleural fistula Through completion of follow-up (30 days) Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures
- Secondary Outcome Measures
Name Time Method Mortality Through completion of follow-up (30 days) Death from any cause
ICU length of stay Through completion of follow-up (30 days) If participant required ICU admission
Change from baseline in dyspnea, measured by the modified Medical Research Council scale Baseline, 2 weeks and 4 weeks after surgery Scores are measured on a scale from 0 to 4, with 0 indicating dyspnea only with strenuous exercise and 4 indicating participant is too dyspneic to leave the house or breathless when dressing
Hospital length of stay Through completion of follow-up (30 days) Total length of index admission following surgery
Chest tube duration Through completion of follow-up (30 days) Number of days from chest tube insertion (surgery date) until chest tube removal
Hospital readmission Through completion of follow-up (30 days) Participant visited an emergency department and/or was admitted to the hospital following discharge from the index admission for any reason.
Trial Locations
- Locations (1)
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States