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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05861089
Other study ID # 17V/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date January 31, 2026

Study information

Verified date November 2023
Source St. Anne's University Hospital Brno, Czech Republic
Contact Ivan Cundrle, MD, PhD
Phone +420543182553
Email cundrle@fnusa.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date January 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - indication for major vascular surgery (aortobifemoral bypass surgery) Exclusion Criteria: - tracheostomy

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Czechia St. Anne's University Hospital in Brno Brno Czech Republic

Sponsors (1)

Lead Sponsor Collaborator
St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Patel SK, Surowiec SM. Intermittent Claudication [Internet]. StatPearls [Internet]. StatPearls Publishing; 2022 [cit 11. január 2023]. Available at: https://www.ncbi.nlm.nih.gov/books/NBK430778/

Outcome

Type Measure Description Time frame Safety issue
Primary pulmonary complications post-operative complications first 30-post operative days
Primary post-operative complications cardiovascular complications first 30-post operative days
Secondary hospital length of stay hospital length of stay up to 30 days
Secondary intensive care unit length of stay intensive care unit length of stay up to 30 days
Secondary mortality mortality from the first 30-post operative days
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