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

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

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 Overview

• Status: Terminated
• Conditions: Postoperative Respiratory Complication
• Intervention / Treatment: Other: Inspiratory muscle training

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Pauline H Go, MD, Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• 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.
• Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise testing screening and pre-operative pulmonary rehabilitation reduce postoperative complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. Thorac Cancer. 2015 Jul;6(4):443-9. doi: 10.1111/1759-7714.12199. Epub 2014 Dec 22.
• Pehlivan E, Turna A, Gurses A, Gurses HN. The effects of preoperative short-term intense physical therapy in lung cancer patients: a randomized controlled trial. Ann Thorac Cardiovasc Surg. 2011;17(5):461-8. doi: 10.5761/atcs.oa.11.01663. Epub 2011 Jul 13.
• Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Inspiratory Muscle Training; Incentive Spirometry; Pulmonary Resection
• Other Study ID Numbers: STUDY00015501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No