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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care + Inspiratory Muscle Training (IMT) | Experimental |
| |
| Usual care (no IMT) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training (IMT) | Other | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gasthuisberg | Leuven | Belgium | ||||
| HUS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29603130 | Derived | Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803. | |
| 24767575 |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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 |
| Helsinki |
| Finland |
| St. James's Hospital | Dublin | Ireland |
| Zorggroep Twente | Almelo | Netherlands |
| VU Medical Center | Amsterdam | Netherlands |
| Reinier de Graaf Gasthuis | Delft | Netherlands |
| Atrium Medical Center | Heerlen | Netherlands |
| Canisius Wilhelmina Hospital | Nijmegen | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Derived |
| Valkenet K, Trappenburg JC, Gosselink R, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJ, de Heus SC, Reynolds JV, Guinan E, Ruurda JP, Rodrigo EH, Nafteux P, Fontaine M, Kouwenhoven EA, Kerkemeyer M, van der Peet DL, Hania SW, van Hillegersberg R, Backx FJ. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15:144. doi: 10.1186/1745-6215-15-144. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |