Incentive Spirometry Prehabilitation Study

Study Overview
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Brief Summary
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Postoperative pulmonary complications (PPCs) are the most common complication following thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity, mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative optimization in this patient group includes smoking cessation and management of Chronic Obstructive Pulmonary Disease with inhaled bronchodilators and inhaled steroids as indicated. There have been studies using preoperative incentive spirometry in patients undergoing laparotomy with conflicting results, but scant data on its use in patients undergoing one-lung ventilation (Tyson, et al., 2015; Cattano, et al., 2010). A study from 2013 investigated the effectiveness of incentive spirometry in patients following thoracotomy and found conflicting results, without significant improvement in lung function or reduction in PPCs, but a larger difference in frequency of PPC was noted, indicating possible benefit to intervention and a need for further study (Agostini, et al., 2013). Volume-based incentive spirometry pre- and postoperatively has also been found to improve pulmonary function and diaphragm excursion in patients undergoing laparoscopic surgery (Alaparthi, et al., 2016). Patients customarily receive an incentive spirometer for use postoperatively in the PACU. There is scant data in the thoracic surgery population concerning prehabilitation by dispensing the incentive spirometer at the PACT evaluation.

Official Title
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Pulmonary Prehabilitation With Incentive Spirometry in Patients Undergoing One-Lung Ventilation and the Effect on Postoperative Lung Function: A Randomized-Controlled Trial

Conditions
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Pulmonary Disease

Intervention / Treatment
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* Behavioral: Spirometry Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for thoracic surgery procedures involving one-lung ventilation open thoracotomy Video-assisted thoracoscopic surgery (VATS) Robotic-assisted thoracoscopic surgery (RATS) Procedures to include: Lung resection for any purpose, esophagectomy, thymectomy Patients undergoing esophagectomy performed by a general surgeon Patients willing and able to independently perform incentive spirometry Exclusion Criteria: Trauma patients Lung Volume reduction surgery (LVRS) In-Patients Patients not undergoing one-lung ventilation Patients undergoing thoracoabdominal aortic aneurysm repair Transhiatal esophagectomy (does not involve one-lung ventilation) Lung transplantation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Spirometry Group<br> | Behavioral: Spirometry Group<br>* Patients that are provided the incentive spirometer pre-operatively and instructed to use it for 4 cycles of 10 spirometry attempts on the day prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Volumes | Mean Lung Volumes | From the time of admission to the pre-operative holding area to 72 hours post-operatively |