PREOPERATIVE INSPIRATORY MUSCLE TRAINING TO REDUCE PNEUMONIA AFTER ESOPHAGECTOMY: THE RESULTS OF THE PREPARE STUDY, AN INTERNATIONAL MULTICENTER RCT

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Valkenet K.1, Trappenburg J.2, van Hillegersberg R.3, Gosselink R.4, Nafteux P.5, Guinan E.6, Reynolds J.V.7, Backx F.1
1UMC Utrecht, Rehabilitation, Physiotherapy Science and Sport, Utrecht, Netherlands, 2UMC Utrecht, Julius Center, Utrecht, Netherlands, 3UMC Utrecht, Surgery, Utrecht, Netherlands, 4University Hospital Leuven, Rehabilitation, Leuven, Belgium, 5University Hospital Leuven, Surgery, Leuven, Belgium, 6Trinity College Dubliin, Physiotherapy, Dublin, Ireland, 7St James' Hospital, Surgery, Dublin, Ireland

Background: Major respiratory complications occur in up to 40% of patients undergoing esophagectomy, and represent the major cause of postoperative mortality. Inspiratory muscle training has shown to reduce postoperative pneumonia by 50% after cardiac surgery but the results in other surgery groups remain uncertain. This highlights the need to investigate the effectiveness of this intervention in other major surgery candidates.

Purpose: To determine whether a preoperative inspiratory muscle training program can reduce the incidence of pneumonia after esophagectomy.

Methods: Design: An international multicenter randomized controlled trial. Setting: In total 9 hospitals (5 academic hospitals) participated: 6 in the Netherlands, 1 in Belgium, 1 in Ireland and 1 in Finland. Participants: Patients undergoing esophagectomy. Intervention: A preoperative high intensity inspiratory muscle training program. Patients in the intervention group performed 30 inspiratory maneuvers 2 times a day for at least 2 weeks until surgery, starting at 60% of their maximal inspiratory muscle strength. Main outcomes and measures: The primary outcome measure was the incidence of postoperative pneumonia, measured using the Uniform Pneumonia Score. Secondary outcomes were inspiratory muscle function, pulmonary function, postoperative complication rates, length of hospital stay and quality of life.

Results: In total 241 patients were included. Postoperative pneumonia was diagnosed in 47 (39.2%) patients in the intervention group and in 43 (35.5%) patients in the control group (p=0.56), relative risk 0.10 (-0.23-0.43). In addition, there were no significant differences between groups for any of the other postoperative outcome measures. Maximal inspiratory muscle strength increased from 76.2±26.4 to 89±29.4 cmH2O (p 0.001) in the intervention group and from 74±30.2 to 80±30.1 in the control group (p 0.001), and was preserved after surgery in the intervention group. Preoperative inspiratory muscle endurance increased from 4:14 to 7:17 minutes in the intervention group (p 0.001) and from 4:20 to 5:05 minutes in the control group (p=0.01). Both mean differences in inspiratory muscle function were significantly higher in the intervention group (p 0.001).

Conclusion(s): Despite a significant increase in preoperative inspiratory muscle function, preoperative inspiratory muscle training did not result in decreased postoperative pneumonia or improved postoperative outcome after esophagectomy.

Implications: We do not recommend the use IMT in the preoperative phase of esophagectomy patients. To increase the impact of interventions aimed at improving pre- and postoperative physical fitness of patients undergoing major surgery, efforts need to be combined.

Funding acknowledgements: The PREPARE trial received funding from 'NutsOhra Foundation' and 'The Friends of the UMC Utrecht Foundation'.

Topic: Cardiorespiratory

Ethics approval: UMC Utrecht ethics committee approved the study in the Netherlands, local independent ethics committees approved for the foreign centers


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