Preoperative respiratory training with incentive spirometry for prevention of pulmonary complications after liver surgery - Monocentric Randomized Controlled Pilot Tria l

Not Applicable

• Conditions: C22; C78.7; Malignant neoplasm of liver and intrahepatic bile ducts; Secondary malignant neoplasm of liver and intrahepatic bile duct

• Registration Number: DRKS00030325
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-07-25
• Study Start: 2022-09-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Indication for elective open liver resection
- Study participation at least 2 weeks preoperatively
- ASA I-III
- Compliance to the feasibility of the training sessions
- Written and verbal informed consent
- General anesthesia with protective lung ventilation

Exclusion Criteria

- Contraindication to surgical liver resection
- Previous lung surgery
- Multivisceral resection, partial diaphragmatic resection
- ALLPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy)
- Liver cirrhosis CHILD B or C
- Heart failure >NYHA III
- Pulmonary artery embolism in the last 6 months
- Venous thrombosis in the last 6 months
- Mental disorders
- Unable to complete training sessions
- Pregnancy/ Lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to investigate the impact of standardized preoperative respiratory training on pulmonary function and defined postoperative pulmonary complications.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are the analysis of cost-bearing factors in the perioperative course (stay in the intensive care unit, length of hospital stay). Further a risk stratification of cardiopulmonary morbidity and mortality wil be made using the 6-minute walk test and spiroergometric findings. The use of the respiratory trainer will<br>be evaluated for practicability and benefit.