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.
Rationale: Esophageal resection is associated with high incidences of postoperative pulmonary pneumonia. Numbers of 30% are reported in literature. Postoperative complications can result in prolonged hospital stay and increased health care costs. In cardiac surgery patients a reduction of postoperative pneumonia of 50% is reported as a result of a preoperative inspiratory muscle training program. While in some surgical centers IMT is already used in the preoperative phase in patients undergoing esophageal resection, the effect of this promising intervention has not yet been investigated in a randomised and controlled study design in large surgical populations other than cardiac surgery. Primary objective: Investigate the effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection. Study design: Prospective multicenter randomised controlled clinical trial. Main study parameters/endpoints: A significant reduction in incidence of postoperative pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
245
The IMT protocol is tailored individually. Inspiratory load is set at 60% of the measured maximal inspiratory pressure (Pimax). The load is incrementally increased based on the rate of perceived exertion (RPE) scored on a scale from 0 to 10 which is scored by the patient after each training session. When patients score an RPE below 7, patients increase the inspiratory load of the threshold device with 5% to guarantee overload during each training session. Patients have to complete 30 dynamic inspiratory efforts twice daily. Patients will be instructed to train at home 7 days a week until surgery with a minimum of 2 weeks. Training will be started after the chemoradiation period (if applicable).
University Hospital Gasthuisberg
Leuven, Belgium
HUS
Helsinki, Finland
St. James's Hospital
Dublin, Ireland
Zorggroep Twente
Almelo, Netherlands
Pneumonia incidence
Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.
Time frame: Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of stay
Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay.
Time frame: Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)
Duration of mechanical ventilation
Number of hours spent on the mechanical ventilator during and directly following the primary surgery.
Time frame: Time between intubation and first extubation (in general no more then 24 hours)
Respiratory muscle function
Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max).
Time frame: At baseline, before surgery and 3, 6 and 9 days after surgery.
Pulmonary function
Forced Expiratory Volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio.
Time frame: At baseline, before surgery and 3, 6 and 9 days after surgery.
Quality of life
Quality of life is measured using the EuroQol and SF-12 questionnaires.
Time frame: At baseline and 4 weeks after surgery
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