Rest PETCO2 As a Predictor of Post-operative Complications

Recruiting

• Conditions: Post-Op Complication

• Registration Number: NCT05861089
• Lead Sponsor: St. Anne's University Hospital Brno, Czech Republic

Brief Summary

Cardiopulmonary exercise testing (CPET) is considered to be a golden standard in preoperative risk assessment and stratification of high risk patients scheduled for major surgery. However, not all of the patients requiring surgery are willing or able to complete this type of testing.

Vascular surgery patients are predominantly elderly people, with significant comorbidity and high degree of frailty and often can not undergo CPET. In recent years, new parameters with similar prognostic value as standard CPET parameters were studied. Specifically, the partial pressure of end-tidal carbon dioxide (PETCO2) at rest has been shown to have the same prognostic value as ventilatory efficiency.

We hypothesized low PETCO2 at rest will be associated with the development of pulmonary and cardiovascular post-operative complications in patients after major vascular surgery. Accordingly, our aim is to compare PETCO2 measured at rest before surgery in patients who develop post-operative complications and in those who do not.

Detailed Description

Cardiopulmonary exercise testing (CPET) is considered to be a golden standard in preoperative risk assessment and stratification of high risk patients scheduled for major surgery. However, not all of the patients requiring surgery are willing or able to complete this type of testing. Moreover, inability to perform CPET has been linked with inferior outcomes following surgery.

Vascular surgery patients are predominantly elderly people, with significant comorbidity and high degree of frailty. Therefore, CPET as a mean of risk stratification would be of an especial interest in this group of patients. However, vascular surgery patients often present with peripheral arterial disease, which may contribute to early leg ischemia during exercise and therefore invalid cardiorespiratory reserve function measurement.

In recent years, new parameters with similar prognostic value as standard CPET parameters were studied. Specifically, the partial pressure of end-tidal carbon dioxide (PETCO2) at rest has been shown to have the same prognostic value as ventilatory efficiency in the prediction of post-operative complications in lung resection surgery patients. Whether the same parameter can be used to predict postoperative complications in a different sub-set of surgical patients (i.e. vascular surgery patients) is yet to be determined.

We hypothesized low PETCO2 at rest will be associated with the development of pulmonary and cardiovascular post-operative complications in patients after major vascular surgery. Accordingly, our aim is to compare PETCO2 measured at rest before surgery in patients who develop post-operative complications and in those who do not.

Study Timeline

• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-16
• Study Start: 2023-06-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• indication for major vascular surgery (aortobifemoral bypass surgery)

Exclusion Criteria

• tracheostomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post-operative complications	first 30-post operative days	cardiovascular complications
pulmonary complications	first 30-post operative days	post-operative complications

Secondary Outcome Measures

Name	Time	Method
hospital length of stay	up to 30 days	hospital length of stay
intensive care unit length of stay	up to 30 days	intensive care unit length of stay
mortality	from the first 30-post operative days	mortality

Trial Locations

Locations (1)

St. Anne's University Hospital in Brno; 🇨🇿 Brno, Czech Republic, Czechia