Clinical trial NCT04732143: Effect of Preoperative Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
Official title: The Effect of Preoperative Inspiratory Muscle Training Using Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Respiratory Complication
Keywords: Incentive Spirometry
Inspiratory Muscle Training
Pulmonary Resection
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Atelectasis
timeFrame: Through completion of follow-up (30 days)
measure: Pneumonia
timeFrame: Through completion of follow-up (30 days)
measure: Respiratory failure
timeFrame: Through completion of follow-up (30 days)
measure: Pleural effusion
timeFrame: Through completion of follow-up (30 days)
measure: Pneumothorax or subcutaneous emphysema
timeFrame: Through completion of follow-up (30 days)
measure: Prolonged air leak
timeFrame: Through completion of follow-up (30 days)
measure: Need for supplemental oxygen
timeFrame: Through completion of follow-up (30 days)
measure: Empyema/bronchopleural fistula
timeFrame: Through completion of follow-up (30 days)
measure: Cardiac arrhythmia
timeFrame: Through completion of follow-up (30 days)
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Through completion of follow-up (30 days)
measure: ICU length of stay
timeFrame: Through completion of follow-up (30 days)
measure: Chest tube duration
timeFrame: Through completion of follow-up (30 days)
measure: Hospital readmission
timeFrame: Through completion of follow-up (30 days)
measure: Change from baseline in dyspnea, measured by the modified Medical Research Council scale
timeFrame: Baseline, 2 weeks and 4 weeks after surgery
measure: Mortality
timeFrame: Through completion of follow-up (30 days)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Pauline H Go, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.
citation: Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.