Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial
نویسندگان
چکیده
BACKGROUND Esophageal 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/DESIGN The 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. DISCUSSION 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. TRIAL REGISTRATION NCT01893008.
منابع مشابه
Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study.
OBJECTIVE To investigate the feasibility and effects of preoperative inspiratory muscle training on the incidence of atelectasis in patients at high risk of postoperative pulmonary complications scheduled for elective abdominal aortic aneurysm surgery. DESIGN Single-blind randomized controlled pilot study. SETTING Gelderse Vallei Hospital Ede, the Netherlands. SUBJECTS Twenty high-risk pa...
متن کاملPostoperative outcomes following preoperative inspiratory muscle training in patients undergoing open cardiothoracic or upper abdominal surgery: protocol for a systematic review
UNLABELLED BACKGROUND In patients undergoing open cardiothoracic and upper abdominal surgery, postoperative pulmonary complications remain an important cause of postoperative morbidity and mortality, impacting upon hospital length of stay and health care resources. Adequate preoperative respiratory muscle strength may help protect against the development of postoperative pulmonary complicati...
متن کاملPreoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial.
CONTEXT Postoperative pulmonary complications (PPCs) after coronary artery bypass graft (CABG) surgery are a major source of morbidity and mortality, and increase length of hospital stay and resource utilization. The prehospitalization period before CABG surgery may be used to improve a patient's pulmonary condition. The efficacy of preoperative inspiratory muscle training (IMT) in reducing the...
متن کاملPreoperative pulmonary rehabilitation versus chest physical therapy in patients undergoing lung cancer resection: a pilot randomized controlled trial.
OBJECTIVE To evaluate the effect of 4 weeks of pulmonary rehabilitation (PR) versus chest physical therapy (CPT) on the preoperative functional capacity and postoperative respiratory morbidity of patients undergoing lung cancer resection. DESIGN Randomized single-blinded study. SETTING A teaching hospital. PARTICIPANTS Patients undergoing lung cancer resection (N=24). INTERVENTIONS Pati...
متن کاملPreoperative ambulatory inspiratory muscle training in patients undergoing esophagectomy. A pilot study.
A major decline in pulmonary function is observed on the first day after upper abdominal surgery. This decline can reduce vital and inspiratory capacity and can culminate in restrictive lung diseases that cause atelectasis, reduced diaphragm movement, and respiratory insufficiency. The objective of this study was to evaluate the efficacy of preoperative ambulatory respiratory muscle training in...
متن کامل