NCT04558151

Randomized-controlled Trial of Preoperative Inspiratory Muscle Training on Postoperative Complications

Randomized-controlled Trial of Spirometry-Assisted Preoperative INSPIRAtory Muscle Training on Postoperative Complications in Abdominal Surgery in a Single Tertiary Referral Centre

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Rehabilitation strategies after abdominal surgery enhance recovery and improve outcome. A cornerstone of rehabilitation is respiratory physiotherapy with inspiratory muscle training to enhance pulmonary function. Prehabilitation is the process of enhancing functional capacity before surgery in order to compensate for the stress of surgery and postoperative recovery. There is growing interest in deploying pre-habilitation interventions prior to surgery. The aim of this study is to assess the impact of preoperative inspiratory muscle training on postoperative overall morbidity. The question is, whether inspiratory muscle training prior to elective abdominal surgery reduces the number of postoperative complications and their severity grade.

Detailed description

INSPIRA is a prospective randomized-controlled single-center trial, non-blinded The aim of this study is to assess the impact of preoperative inspiratory muscle training on postoperative overall morbidity. The question is, whether inspiratory muscle training prior to elective abdominal surgery reduces the number of post-operative complications and their severity grade. Furthermore, the impact of preoperative inspiratory muscle training on postoperative physiotherapeutic performance as surrogate of convalescence is assessed, too. Patients will be instructed by physiotherapists to perform inspiratory muscle training containing of 30 breaths twice a day for 14-18 days before surgery using Power®Breathe KHP2. Primary outcome is Comprehensive Complication Index (CCI) at 90 days after surgery. The CCI expresses morbidity on a con-tinuous numeric scale from 0 (no complication) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity.

Conditions

• Postoperative Complications
• Breathing Exercises
• Preoperative Period

Interventions

Type	Name	Description
BEHAVIORAL	preoperative inspiratory muscle training	Physiotherapists will measure the maximal inspiration pressure (MIP) with the POWER®breathe device of each single patient. Patients will then be instructed to perform inspiratory muscle training at the level of 60% of their individual MIP. Patients are instructed to perform the training containing of 30 breaths twice a day for 14-18 days before surgery. The devices are able to register the performance of each single training session and training results are monitored.

Timeline

• Start date: 2021-08-13
• Primary completion: 2025-10-08
• Completion: 2025-10-08
• First posted: 2020-09-22
• Last updated: 2026-01-07

Locations

1 site across 1 country: Switzerland