Preoperative Inspiratory Muscle Training in Esophageal Resection (PREPARE)
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|ClinicalTrials.gov Identifier: NCT01893008|
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Resection Candidates||Other: Inspiratory Muscle Training (IMT)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
|Experimental: Usual care + Inspiratory Muscle Training (IMT)||
Other: Inspiratory Muscle Training (IMT)
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).
|No Intervention: Usual care (no IMT)|
- Pneumonia incidence [ Time Frame: Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.
- Length of stay [ Time Frame: Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days) ]Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay.
- Duration of mechanical ventilation [ Time Frame: Time between intubation and first extubation (in general no more then 24 hours) ]Number of hours spent on the mechanical ventilator during and directly following the primary surgery.
- Respiratory muscle function [ Time Frame: At baseline, before surgery and 3, 6 and 9 days after surgery. ]Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max).
- Pulmonary function [ Time Frame: At baseline, before surgery and 3, 6 and 9 days after surgery. ]Forced Expiratory Volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio.
- Quality of life [ Time Frame: At baseline and 4 weeks after surgery ]Quality of life is measured using the EuroQol and SF-12 questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893008
|University Hospital Gasthuisberg|
|St. James's Hospital|
|VU Medical Center|
|Reinier de Graaf Gasthuis|
|Atrium Medical Center|
|Canisius Wilhelmina Hospital|