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

Penn State Health

Status: Terminated

Conditions: Postoperative Respiratory Complication

Treatments: Other: Inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT04732143

STUDY00015501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Incentive Spirometry

Experimental group

Description:

Participants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery.

Treatment:

Other: Inspiratory muscle training

Standard Care

No Intervention group

Description:

Participants will not undergo any inspiratory muscle training prior to surgery.