Preoperative Inspiratory Muscle Training in Esophageal Resection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection

Conditions
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Esophageal Resection Candidates

Intervention / Treatment
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* Other: Inspiratory Muscle Training (IMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (Cognitively) capable to understand and perform a preoperative IMT program Surgery is scheduled at least 2 weeks after signing informed consent, since the patients need to be able to follow the intervention program for at least 2 weeks Willing to sign the informed consent form Exclusion Criteria: Unable to communicate in Dutch language Age < 18 years Participating in a conflicting trial concerning esophageal resection

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual care + Inspiratory Muscle Training (IMT)<br> | Other: Inspiratory Muscle Training (IMT)<br>* 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).<br>|
| No Intervention: Usual care (no IMT)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia incidence | Pneumonia will be scored according to the Utrecht Pneumonia Scoring System. | Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay. | 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 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). | 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. | 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. | At baseline and 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer, Surgery