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

Milton S. Hershey Medical Center25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Postoperative Respiratory Complication

Interventions

Inspiratory muscle trainingOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Atelectasis

Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist

Time frame: Through completion of follow-up (30 days)

Pneumonia

Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy

Time frame: 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

Time frame: Through completion of follow-up (30 days)

Pleural effusion

Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics)

Time frame: 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

Time frame: Through completion of follow-up (30 days)

Prolonged air leak

Incidence of prolonged air leak (\>5 days) or requiring discharge with chest tube

Time frame: Through completion of follow-up (30 days)

Need for supplemental oxygen

Incidence of patients requiring supplemental oxygen upon discharge

Time frame: Through completion of follow-up (30 days)

Empyema/bronchopleural fistula

Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures

Data from ClinicalTrials.gov

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Secondary Outcomes

Hospital length of stay

Total length of index admission following surgery

Time frame: Through completion of follow-up (30 days)

ICU length of stay

If participant required ICU admission

Time frame: Through completion of follow-up (30 days)

Chest tube duration

Number of days from chest tube insertion (surgery date) until chest tube removal

Time frame: 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.

Time frame: 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

Time frame: Baseline, 2 weeks and 4 weeks after surgery

Mortality

Death from any cause

Time frame: Through completion of follow-up (30 days)