Clinical trial NCT04558151: Randomized-controlled Trial of Preoperative Inspiratory Muscle Training on Postoperative Complications
Official title: Randomized-controlled Trial of Spirometry-Assisted Preoperative INSPIRAtory Muscle Training on Postoperative Complications in Abdominal Surgery in a Single Tertiary Referral Centre
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Breathing Exercises
Preoperative Period
Keywords: inspiratory muscle training
CCI
postoperative complications
prehabilitation
preoperative respiratory training
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Lunge Zuerich
First posted: 2020-09-22
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized-controlled single-center trial, non-blinded
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Patient Informed Consent Form)
* Planned abdominal surgery with planned duration \>2hours (disease localization: upper vs. lower gastro intestinal, HPB, hernia, others)
* Planned surgery at least two weeks after inclusion at outpatient clinic
* Male and female patient over 18 years

Exclusion Criteria:

* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, of the participant
* Known or suspected non-compliance, drug or alcohol abuse,
* Previous enrolment into the current study
* Participation in another study with inspiratory muscle training within 30 days preceding or during this study

Primary outcomes:
measure: Postoperative complications
timeFrame: 90 days postoperative
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: At the end of hospitalization and 90 days +/- 2 weeks postoperative
measure: Length of hospital stay (LOS)
timeFrame: 90 days postoperative
measure: Readmission rate
timeFrame: 90 days postoperative
measure: Mortality
timeFrame: 90 days postoperative
measure: Maximum inspiratory pressure (MIP)
timeFrame: 5 days after surgery
measure: Load
timeFrame: 5 days after surgery
measure: Power (Watt)
timeFrame: 5 days after surgery
measure: Sit-to-stand test
timeFrame: 5 days after surgery
measure: Energy (Joule)
timeFrame: 5 days after surgery
measure: Volume (l)
timeFrame: 5 days after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitätsSpital Zürich (USZ)
name: Dominique Lisa Birrer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birrer DL, Kuemmerli C, Obwegeser A, Liebi M, von Felten S, Pettersson K, Horisberger K. INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery. Trials. 2022 Jun 7;23(1):473. doi: 10.1186/s13063-022-06254-4.