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Lack of funding and clinical resources to continue
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incentive Spirometry | Experimental | Participants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery. |
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| Standard Care | No Intervention | Participants will not undergo any inspiratory muscle training prior to surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle training | Other | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline H Go, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21881371 | Background | 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. | |
| 26273399 | Background | 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. |
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| 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) |
| 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) |
| 29603130 | Background | 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. |
| 9081102 | Background | 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. |
| 21663994 | Background | 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. |