Clinical trial NCT01893008: Preoperative Inspiratory Muscle Training in Esophageal Resection
Official title: Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Resection Candidates
Keywords: Esophageal cancer
Surgery
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pneumonia incidence
timeFrame: Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Length of stay
timeFrame: Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)
measure: Duration of mechanical ventilation
timeFrame: Time between intubation and first extubation (in general no more then 24 hours)
measure: Respiratory muscle function
timeFrame: At baseline, before surgery and 3, 6 and 9 days after surgery.
measure: Pulmonary function
timeFrame: At baseline, before surgery and 3, 6 and 9 days after surgery.
measure: Quality of life
timeFrame: At baseline and 4 weeks after surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Helsinki
country: Finland
facility: HUS
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Almelo
country: Netherlands
facility: Zorggroep Twente
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Heerlen
country: Netherlands
facility: Atrium Medical Center
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References:
citation: 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.
citation: 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.