Open Access Study protocol

Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial

Karin Valkenet1*, Jaap CA Trappenburg1, Rik Gosselink2, Meindert N Sosef3, Jerome Willms4, Camiel Rosman5, Heleen Pieters6, Joris JG Scheepers7, Saskia C de Heus8, John V Reynolds9, Emer Guinan10, Jelle P Ruurda11, Els HE Rodrigo1, Philippe Nafteux12, Marianne Fontaine13, Ewout A Kouwenhoven14, Margot Kerkemeyer15, Donald L van der Peet16, Sylvia W Hania17, Richard van Hillegersberg11 and Frank JG Backx1

Author Affiliations

1 Department of Rehabilitation, Nursing Science and Sports, University Medical Center Utrecht, PO Box 85500, Utrecht 3508 GA, The Netherlands

2 Department of Rehabilitation Sciences, KU Leuven, University Hospital Leuven, Tervuursevest 101, Leuven 3001, Belgium

3 Department of Surgery, Atrium Medical Center, PO Box 4446, Heerlen 6401 CX, The Netherlands

4 Department of Physical Therapy, Atrium Medical Center, PO Box 4446, Heerlen 6401 CX, The Netherlands

5 Department of Surgery, Canisius Wilhelmina Hospital, PO Box 9015, Nijmegen 6500 GS, The Netherlands

6 Department of Physical Therapy, Canisius Wilhelmina Hospital, PO Box 9015, Nijmegen 6500 GS, The Netherlands

7 Department of Surgery, Reinier de Graaf Hospital, PO Box 5011, Delft 2600 GA, The Netherlands

8 Department of Physical Therapy, Reinier de Graaf Hospital, PO Box 5011, Delft 2600 GA, The Netherlands

9 Department of Surgery, St James’s Hospital, Trinity Centre for Health Sciences, Dublin 8, Ireland

10 Discipline of Physiotherapy, St James’s Hospital, Trinity Centre for Health Sciences, Dublin 8, Ireland

11 Department of Surgery, University Medical Center Utrecht, PO Box 85500, Utrecht 3508 GA, The Netherlands

12 Department of Thoracic Surgery, University Hospitals Leuven, Herestraat 49 3000, Leuven, Belgium

13 Department of Physical Therapy, University Hospitals Leuven, Herestraat 49 3000, Leuven, Belgium

14 Department of Surgery, Hospital Group Twente (ZGT), PO Box 7600, Almelo 7600 SZ, The Netherlands

15 Department of Physical Therapy, Hospital Group Twente (ZGT), PO Box 7600, Almelo 7600 SZ, The Netherlands

16 Department of Surgery, VU University Medical Center, PO Box 7057, Amsterdam 1007 MB, The Netherlands

17 Department of Physical Therapy, VU University Medical Center, PO Box 7057, Amsterdam 1007 MB, The Netherlands

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Trials 2014, 15:144  doi:10.1186/1745-6215-15-144

Published: 27 April 2014

Abstract

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/Design

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.

Discussion

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.

Trial registration

NCT01893008.

Keywords:
Inspiratory muscle training; Physical therapy; Preoperative; Esophageal resection; Pneumonia