Esophageal Resection Candidates
Conditions
Keywords
Esophageal cancer, Surgery
Brief summary
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
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.
Interventions
OTHERInspiratory 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).
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumonia incidence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | 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 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 | 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 | 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 | At baseline and 4 weeks after surgery | Quality of life is measured using the EuroQol and SF-12 questionnaires. |
Countries
Belgium, Finland, Ireland, Netherlands
Outcome results
None listed