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

Postoperative Respiratory Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04732143
• Other study ID #: STUDY00015501
• Status: Terminated
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: June 7, 2023

Study information

• Verified date: June 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Respiratory Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atelectasis	Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist	Through completion of follow-up (30 days)
Primary	Pneumonia	Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy	Through completion of follow-up (30 days)
Primary	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)
Primary	Pleural effusion	Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics)	Through completion of follow-up (30 days)
Primary	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)
Primary	Prolonged air leak	Incidence of prolonged air leak (>5 days) or requiring discharge with chest tube	Through completion of follow-up (30 days)
Primary	Need for supplemental oxygen	Incidence of patients requiring supplemental oxygen upon discharge	Through completion of follow-up (30 days)
Primary	Empyema/bronchopleural fistula	Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures	Through completion of follow-up (30 days)
Primary	Cardiac arrhythmia	Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)	Through completion of follow-up (30 days)
Secondary	Hospital length of stay	Total length of index admission following surgery	Through completion of follow-up (30 days)
Secondary	ICU length of stay	If participant required ICU admission	Through completion of follow-up (30 days)
Secondary	Chest tube duration	Number of days from chest tube insertion (surgery date) until chest tube removal	Through completion of follow-up (30 days)
Secondary	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)
Secondary	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
Secondary	Mortality	Death from any cause	Through completion of follow-up (30 days)