Hershey, Pennsylvania 17033

  • Postoperative Respiratory Complication

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT04732143


Primary Contact:

Principal Investigator
Pauline H Go, MD
Milton S. Hershey Medical Center

Pauline H Go, MD
Phone: 717-531-5429
Email: paulinego@pennstatehealth.psu.edu


Backup Contact:

Email: rperezholguin@pennstatehealth.psu.edu
Rolfy Perez Holguin, MD


Location Contact:

Hershey, Pennsylvania 17033
United States

Pauline H Go, MD
Phone: 717-531-5429
Email: paulinego@pennstatehealth.psu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.