Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT04558151
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2020-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized-controlled Trial of Preoperative Inspiratory Muscle Training on Postoperative Complications
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Randomized-controlled Trial of Spirometry-Assisted Preoperative INSPIRAtory Muscle Training on Postoperative Complications in Abdominal Surgery in a Single Tertiary Referral Centre
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRA
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: