Rest PETCO2 as a Predictor of Post-operative Complications

Sponsor
St. Anne's University Hospital Brno, Czech Republic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05861089
Collaborator
(none)
130
1
32
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: end-tidal CO2 measurement

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 Design

Study Type:
Observational
Anticipated Enrollment :
130 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Rest PETCO2 as a Predictor of Post-operative Complications in Patient Undergoing Major Vascular Surgery
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Jan 31, 2026

Arms and Interventions

Arm Intervention/Treatment
vascular surgery candidates

End-tidal CO2 will be measured day before surgery. Post-operative cardiovascular and pulmonary complications will be monitored fron the hospital stay, or first 30 days.

Diagnostic Test: end-tidal CO2 measurement
Measurements will take place day before surgery, under resting conditions (while sitting in a quiet room with no disruptions) using the Capnography monitor from Nonin Medical (breath by breath data will be recorded and analyzed). Patients will be allowed to get used to the nasal cannula for the first two minutes. Mean end-tidal CO2 value will then be calculated from the following two minutes of spontaneous breathing.

Outcome Measures

Primary Outcome Measures

  1. pulmonary complications [first 30-post operative days]

    post-operative complications

  2. post-operative complications [first 30-post operative days]

    cardiovascular complications

Secondary Outcome Measures

  1. hospital length of stay [up to 30 days]

    hospital length of stay

  2. intensive care unit length of stay [up to 30 days]

    intensive care unit length of stay

  3. mortality [from the first 30-post operative days]

    mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • indication for major vascular surgery (aortobifemoral bypass surgery)
Exclusion Criteria:
  • tracheostomy

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Anne's University Hospital in Brno Brno Czech Republic Czechia 60200

Sponsors and Collaborators

  • St. Anne's University Hospital Brno, Czech Republic

Investigators

  • Principal Investigator: Ivan Cundrle, MD, PhD, St. Anne's University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ivan Cundrle, Clinical Professor, St. Anne's University Hospital Brno, Czech Republic
ClinicalTrials.gov Identifier:
NCT05861089
Other Study ID Numbers:
  • 17V/2023
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ivan Cundrle, Clinical Professor, St. Anne's University Hospital Brno, Czech Republic
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023