Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial.
BACKGROUND
Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design.


METHODS
The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function.


CONCLUSIONS
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.


BACKGROUND
NCT01893008.
Department of Rehabilitation, Nursing Science and Sports, University Medical Center Utrecht, PO Box 85500, Utrecht 3508 GA, The Netherlands. k.valkenet@umcutrecht.nl.
Karin
K
Valkenet
Jaap Ca
JC
Trappenburg
Rik
R
Gosselink
Meindert N
MN
Sosef
Jerome
J
Willms
Camiel
C
Rosman
Heleen
H
Pieters
Joris Jg
JJ
Scheepers
Saskia C
SC
de Heus
John V
JV
Reynolds
Emer
E
Guinan
Jelle P
JP
Ruurda
Els He
EH
Rodrigo
Philippe
P
Nafteux
Marianne
M
Fontaine
Ewout A
EA
Kouwenhoven
Margot
M
Kerkemeyer
Donald L
DL
van der Peet
Sylvia W
SW
Hania
Richard
R
van Hillegersberg
Frank Jg
FJ
Backx
D001945:Breathing Exercises; D002985:Clinical Protocols; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects*; D006801:Humans; D001239:Inhalation; D009426:Netherlands; D011014:Pneumonia / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*; D011300:Preoperative Care; D012107:Research Design; D012132:Respiratory Muscles / Q000502:physiology*; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome