Abstract
BackgroundEsophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design.Methods/DesignThe effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function.DiscussionThe PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.Trial registrationNCT01893008.
Highlights
Esophageal resection is associated with a high incidence of postoperative pneumonia
The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection
This article provides a detailed description of the background, the targeted population, and study methodology of the PREPARE study, a multicenter randomized controlled trial (RCT) investigating the effect of preoperative inspiratory muscle training (IMT) in esophageal resection candidates
Summary
The high incidence of pneumonia has large impact on postoperative outcomes after esophageal resection. The PREPARE trial is the first study investigating the effect of preoperative IMT in a multicenter design. The measurements will show whether the effects of preoperative IMT are still present in the postoperative phase and provide data for exploratory analyses on the possible working mechanism of how IMT may prevent PPCs. The PREPARE study is the only study reporting a priori sample size calculation, and is unique in esophageal resection candidates with sufficient statistical power to show reductions in pneumonia events. Other advantages of the POWERbreathe equipment is the tapered flow resistive loading, the gradually increasing load during the first three inspirations, the recording of the average load, average power, average volume, and training index (training effectiveness) This multicenter RCT will investigate the hypothesis that preoperative IMT is associated with reduced postoperative pneumonia following esophageal resection. All authors provided input into revisions of the manuscript and have read and approved the final manuscript
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
