Postoperative Respiratory Complication
Conditions
Keywords
Incentive Spirometry, Inspiratory Muscle Training, Pulmonary Resection
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.
Interventions
OTHERInspiratory muscle training
At least 2 weeks prior to surgery, participants will be given a Vyaire incentive spirometer device and provided with formal training on proper inspiratory muscle breathing exercise using the device. They will be instructed to perform 4 sets of these exercises per day for 14 days prior to surgery.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac arrhythmia | Through completion of follow-up (30 days) | Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.) |
| 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 |
| Pleural effusion | Through completion of follow-up (30 days) | Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics) |
| 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 |
| 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 |
| Atelectasis | Through completion of follow-up (30 days) | Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist |
| Pneumonia | Through completion of follow-up (30 days) | Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | Through completion of follow-up (30 days) | If participant required ICU admission |
| 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. |
| 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 |
| Mortality | Through completion of follow-up (30 days) | Death from any cause |
| Hospital length of stay | Through completion of follow-up (30 days) | Total length of index admission following surgery |
Countries
United States
Outcome results
None listed