Effect of Preoperative Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Preoperative Inspiratory Muscle Training Using Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection

Conditions
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Postoperative Respiratory Complication

Intervention / Treatment
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* Other: Inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incentive Spirometry<br>Participants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery. | Other: Inspiratory muscle training<br>* 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.<br>* Other names: Incentive spirometry;|
| No Intervention: Standard Care<br>Participants will not undergo any inspiratory muscle training prior to surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atelectasis | Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist | Through completion of follow-up (30 days) | 
| Pneumonia | Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy | Through completion of follow-up (30 days) | 
| Respiratory failure | Incidence of respiratory failure requiring re-intubation or high flow nasal cannula and/or non-invasive positive pressure ventilation | Through completion of follow-up (30 days) | 
| Pleural effusion | Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics) | Through completion of follow-up (30 days) | 
| Pneumothorax or subcutaneous emphysema | Incidence of clinically significant pneumothorax or subcutaneous emphysema requiring intervention or extended hospital admission for observation | Through completion of follow-up (30 days) | 
| Prolonged air leak | Incidence of prolonged air leak (>5 days) or requiring discharge with chest tube | Through completion of follow-up (30 days) | 
| Need for supplemental oxygen | Incidence of patients requiring supplemental oxygen upon discharge | Through completion of follow-up (30 days) | 
| Empyema/bronchopleural fistula | Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures | Through completion of follow-up (30 days) | 
| Cardiac arrhythmia | Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.) | Through completion of follow-up (30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Total length of index admission following surgery | Through completion of follow-up (30 days) | 
| ICU length of stay | If participant required ICU admission | Through completion of follow-up (30 days) | 
| Chest tube duration | Number of days from chest tube insertion (surgery date) until chest tube removal | Through completion of follow-up (30 days) | 
| Hospital readmission | Participant visited an emergency department and/or was admitted to the hospital following discharge from the index admission for any reason. | Through completion of follow-up (30 days) | 
| Change from baseline in dyspnea, measured by the modified Medical Research Council scale | 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 | Baseline, 2 weeks and 4 weeks after surgery | 
| Mortality | Death from any cause | Through completion of follow-up (30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incentive Spirometry, Inspiratory Muscle Training, Pulmonary Resection