Post-Op ComplicationNCT05861089
Rest PETCO2 as a Predictor of Post-operative Complications
An observational study of Post-Op Complication, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- end-tidal CO2 measurement
- How many people
- 91 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- indication for major vascular surgery (aortobifemoral bypass surgery)
Who cannot join
- tracheostomy
Trial locations and contacts
1 site in 1 country.
Czechia1 site
St. Anne's University Hospital in Brno
Brno, Czech Republic, 60200
About this study
Official title: Rest PETCO2 as a Predictor of Post-operative Complications in Patient Undergoing Major Vascular Surgery
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.
Read the 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.
- Conditions
- Post-Op Complication
- Being tested
- end-tidal CO2 measurement
- Keywords
- vascular surgery, cardiopulmonary exercise testing, end-tidal CO2
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
end-tidal CO2 measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: end-tidal CO2 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary complications
post-operative complications
Measured: first 30-post operative days
post-operative complications
cardiovascular complications
Measured: first 30-post operative days
Secondary outcomes (3)
hospital length of stay
hospital length of stay
Measured: up to 30 days
intensive care unit length of stay
intensive care unit length of stay
Measured: up to 30 days
mortality
mortality
Measured: from the first 30-post operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic
- Investigators
- Ivan Cundrle, MD, PhD, Principal investigator, St. Anne's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861089
- Sponsor's protocol ID
- 17V/2023
- Status last verified
- Apr 2026
- First submitted
- 6 May 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17989266Keteyian 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.
PubMed 19782792Lai 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.
PubMed 23744818Ambler 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.
PubMed 32417030Barkat 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.
PubMed 33818006Brat 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.
PubMed 35074321Brat 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.
PubMed 27496629Patel 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/
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rest PETCO2 as a Predictor of Post-operative Complications in Patient Undergoing Major Vascular Surgery
- ClinicalTrials.gov ID
- NCT05861089
- Acronym / sponsor ID
- 17V/2023
- Conditions
- Post-Op Complication
- Keywords
- vascular surgery, cardiopulmonary exercise testing, end-tidal CO2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vascular surgery candidates | – | Diagnostic Test: end-tidal CO2 measurementEnd-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- indication for major vascular surgery (aortobifemoral bypass surgery)
Key exclusion criteria (1 listed)
- tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| end-tidal CO2 measurementMeasurements 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. | Diagnostic test | vascular surgery candidates |
Primary outcome
pulmonary complications
Time frame: first 30-post operative days
post-operative complications
post-operative complications
Time frame: first 30-post operative days
cardiovascular complications
3 secondary outcomes
hospital length of stay
Time frame: up to 30 days
intensive care unit length of stay
Time frame: up to 30 days
mortality
Time frame: from the first 30-post operative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 17989266Albouaini 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.
- Background: PubMed 19782792Keteyian 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.
- Background: PubMed 23744818Lai 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.
- Background: PubMed 32417030Ambler 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.
- Background: PubMed 33818006Barkat 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.
- Background: PubMed 35074321Brat 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.
- Background: PubMed 27496629Brat 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.
- BackgroundPatel 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/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Cundrle, MD, PhD principal investigator
St. Anne's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Op Complication, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary complications (time frame: first 30-post operative days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861089, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.