Rest PETCO2 as a Predictor of Post-operative Complications

NCT05861089 | Completed

• 1 other identifier: 17V/2023
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Op Complication

Keywords

vascular surgery; cardiopulmonary exercise testing; end-tidal CO2

Outcome Measures

Primary Outcomes (2)

• pulmonary complications

  post-operative complications

  first 30-post operative days

• post-operative complications

  cardiovascular complications

  first 30-post operative days

Secondary Outcomes (3)

• hospital length of stay

  up to 30 days

• intensive care unit length of stay

  up to 30 days

• mortality

  from the first 30-post operative days

Study Arms (1)

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

Interventions

end-tidal CO2 measurement DIAGNOSTIC_TEST

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.

vascular surgery candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients scheduled for vascular surgery will be recruited. This subset of patients was chosen as it usually presents with a number of serious comorbidities and short claudication interval which makes them indicated to, but unable to complete the standard CPET

You may qualify if:

• indication for major vascular surgery (aortobifemoral bypass surgery)

You may not qualify if:

• tracheostomy

Sponsors & Collaborators

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

Study Sites (1)

St. Anne's University Hospital in Brno

Brno, Czech Republic, 60200, Czechia

Location

Related Publications (8)

• Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.

  PMID: 17989266 BACKGROUND

• Keteyian SJ, Isaac D, Thadani U, Roy BA, Bensimhon DR, McKelvie R, Russell SD, Hellkamp AS, Kraus WE; HF-ACTION Investigators. Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction. Am Heart J. 2009 Oct;158(4 Suppl):S72-7. doi: 10.1016/j.ahj.2009.07.014.

  PMID: 19782792 BACKGROUND

• Lai CW, Minto G, Challand CP, Hosie KB, Sneyd JR, Creanor S, Struthers RA. Patients' inability to perform a preoperative cardiopulmonary exercise test or demonstrate an anaerobic threshold is associated with inferior outcomes after major colorectal surgery. Br J Anaesth. 2013 Oct;111(4):607-11. doi: 10.1093/bja/aet193. Epub 2013 Jun 5.

  PMID: 23744818 BACKGROUND

• Ambler GK, Kotta PA, Zielinski L, Kalyanasundaram A, Brooks DE, Ali A, Chowdhury MM, Coughlin PA. The Effect of Frailty on Long Term Outcomes in Vascular Surgical Patients. Eur J Vasc Endovasc Surg. 2020 Aug;60(2):264-272. doi: 10.1016/j.ejvs.2020.04.009. Epub 2020 May 14.

  PMID: 32417030 BACKGROUND

• Barkat M, Key A, Ali T, Walker P, Duffy N, Snellgrove J, Torella F. Effect of treatment of peripheral arterial disease on the onset of anaerobic exercise during cardiopulmonary exercise testing. Physiol Rep. 2021 Apr;9(7):e14815. doi: 10.14814/phy2.14815.

  PMID: 33818006 BACKGROUND

• Brat K, Homolka P, Merta Z, Chobola M, Heroutova M, Bratova M, Mitas L, Chovanec Z, Horvath T, Benej M, Ivicic J, Svoboda M, Sramek V, Olson LJ, Cundrle I Jr. Prediction of Postoperative Complications: Ventilatory Efficiency and Rest End-tidal Carbon Dioxide. Ann Thorac Surg. 2023 May;115(5):1305-1311. doi: 10.1016/j.athoracsur.2021.11.073. Epub 2022 Jan 21.

  PMID: 35074321 BACKGROUND

• Brat K, Tothova Z, Merta Z, Taskova A, Homolka P, Vasakova M, Skrickova J, Sramek V, Olson LJ, Cundrle I Jr. Resting End-Tidal Carbon Dioxide Predicts Respiratory Complications in Patients Undergoing Thoracic Surgical Procedures. Ann Thorac Surg. 2016 Nov;102(5):1725-1730. doi: 10.1016/j.athoracsur.2016.05.070. Epub 2016 Aug 3.

  PMID: 27496629 BACKGROUND

• Patel SK, Surowiec SM. Intermittent Claudication. 2023 Jul 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430778/

  PMID: 28613529 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan Cundrle, MD, PhD

  St. Anne's University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)