Postoperative ComplicationsNCT06702059
Cardiopulmonary Exercise Testing in Cardiosurgery Patients
An observational study of Postoperative Complications, run by St. Anne's University Hospital Brno, Czech Republic at 2 sites in Czechia.
Trial summary
Cardiopulmonary exercise testing (CPET) is considered to be a gold standard in pre-operative risk assessment and stratification of high risk patients scheduled for major surgery. Surprisingly, only a limited number of studies examined the prognostic role of CPET in cardiothoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Cardiopulmonary exercise testing
- How many people
- 130 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Dec 2024to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for coronary artery bypass graft surgery
Who may be able to join
- patients scheduled for coronary artery bypass graft surgery
Who cannot join
- not able to perform cardiopulmonary exercise testing, off-pump revascularization, without full sternotomy, previous cardiac surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 1 recruiting
- Recruiting
Centre of Cardiovascular and Transplantation Surgery
Brno, Czech Republic, 60200
Marek Lukes, M.D., 00 420 543 182 484, mare.lukes@fnusa.cz
Petr Fila, M.D., Ph.D.
- Active, not recruiting
St. Anne's University Hospital in Brno
Brno, Czech Republic, 61200
About this study
Official title: Cardiopulmonary Exercise Testing in the Prediction of Post-operative Complications in Patients Undergoing Coronary Artery Bypass Graft Surgery
Cardiopulmonary exercise testing (CPET) is considered to be a gold standard in pre-operative risk assessment and stratification of high risk patients scheduled for major surgery. Surprisingly, only a limited number of studies examined the prognostic role of CPET in cardiothoracic surgery. This is in contrast with rather poor discriminating quality of cardiovascular surgery risk scores and predominantly elderly cardiovascular surgery patients, with significant comorbidity and high degree of frailty. Recently, CPET was shown feasible in coronary artery bypass grafting surgery candidates. Additionally, the rest parameter, which is the partial pressure of end-tidal carbon dioxide (PETCO2) and a submaximal exercise parameter (the VE/VCO2 slope) with good prognostic utility across multiple respiratory exchange ratio values), has been shown to predict mortality and post-operative complications.
Whether these rest and submaximal exercise parameters can be used to predict postoperative complications in cardiovascular surgery patients is yet to be determined.
- Conditions
- Postoperative Complications
- Being tested
- Cardiopulmonary exercise testing
- Keywords
- cardiovascular surgery, cardiopulmonary exercise testing, post-operative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testingDiagnostic test
Subjects will undergo pre-operative cardiopulmonary exercise testing.
| Study group | Role | What they receive |
|---|---|---|
| coronary artery bypass graft candidates | patients scheduled for CABG surgery will undergo pre-operative cardiopulmonary exercise testing and post-operative complications monitoring Receives: Diagnostic Test: Cardiopulmonary exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pulmonary complications
pneumonia, atelectasis, respiratory failure, ARDS
Measured: within 30 post-operative days
post-operative cardiovascular complications
new arrhythmias (atrial fibrillation, supraventricular tachycardia, etc.), myocardial infarction/minimal myocardial lesion, hypotension, heart failure, pulmonary edema, pulmonary embolism, cardiopulmonary resuscitation
Measured: within 30 post-operative days
Secondary outcomes (1)
Hospital and Intensive care length of stay
Hospital and Intensive care length of stay
Measured: within 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 posted22 Nov 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Cardiovascular and Transplantation Surgery, Czech Republic
- Responsible party
- Principal investigator, Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic
- Investigators
- Ivan Cundrle, prof., M.D., Principal investigator, St. Anne's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702059
- Sponsor's protocol ID
- 46/2024/OD
- Status last verified
- May 2025
- First submitted
- 20 Nov 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Information will be provided upon reasonable request.
Publications
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.
PubMed 27496629Cundrle I Jr, Merta Z, Bratova M, Homolka P, Mitas L, Sramek V, Svoboda M, Chovanec Z, Chobola M, Olson LJ, Brat K. The risk of post-operative pulmonary complications in lung resection candidates with normal forced expiratory volume in 1 s and diffusing capacity of the lung for carbon monoxide: a prospective multicentre study. ERJ Open Res. 2023 Mar 6;9(2):00421-2022. doi: 10.1183/23120541.00421-2022. eCollection 2023 Mar.
PubMed 36891072Mann J, Williams M, Wilson J, Yates D, Harrison A, Doherty P, Davies S. Exercise-induced myocardial dysfunction detected by cardiopulmonary exercise testing is associated with increased risk of mortality in major oncological colorectal surgery. Br J Anaesth. 2020 Apr;124(4):473-479. doi: 10.1016/j.bja.2019.12.043. Epub 2020 Feb 19.
PubMed 32085879Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.
PubMed 22560968Brat 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 35074321Albouaini 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 17989266
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing in the Prediction of Post-operative Complications in Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06702059
- Acronym / sponsor ID
- 46/2024/OD
- Conditions
- Postoperative Complications
- Keywords
- cardiovascular surgery, cardiopulmonary exercise testing, post-operative complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Collaborators
- Centre of Cardiovascular and Transplantation Surgery, Czech Republic
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 22 Nov 2024 (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 gold standard in pre-operative risk assessment and stratification of high risk patients scheduled for major surgery. Surprisingly, only a limited number of studies examined the prognostic role of CPET in cardiothoracic surgery. This is in contrast with rather poor discriminating quality of cardiovascular surgery risk scores and predominantly elderly cardiovascular surgery patients, with significant comorbidity and high degree of frailty. Recently, CPET was shown feasible in coronary artery bypass grafting surgery candidates. Additionally, the rest parameter, which is the partial pressure of end-tidal carbon dioxide (PETCO2) and a submaximal exercise parameter (the VE/VCO2 slope) with good prognostic utility across multiple respiratory exchange ratio values), has been shown to predict mortality and post-operative complications.
Whether these rest and submaximal exercise parameters can be used to predict postoperative complications in cardiovascular surgery patients is yet to be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery bypass graft candidates | – | Diagnostic Test: Cardiopulmonary exercise testingpatients scheduled for CABG surgery will undergo pre-operative cardiopulmonary exercise testing and post-operative complications monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for coronary artery bypass graft surgery
Key inclusion criteria (1 listed)
- patients scheduled for coronary artery bypass graft surgery
Key exclusion criteria (1 listed)
- not able to perform cardiopulmonary exercise testing, off-pump revascularization, without full sternotomy, previous cardiac surgery
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 |
|---|---|---|
| Cardiopulmonary exercise testingSubjects will undergo pre-operative cardiopulmonary exercise testing. | Diagnostic test | coronary artery bypass graft candidates |
Primary outcome
post-operative pulmonary complications
Time frame: within 30 post-operative days
pneumonia, atelectasis, respiratory failure, ARDS
post-operative cardiovascular complications
Time frame: within 30 post-operative days
new arrhythmias (atrial fibrillation, supraventricular tachycardia, etc.), myocardial infarction/minimal myocardial lesion, hypotension, heart failure, pulmonary edema, pulmonary embolism, cardiopulmonary resuscitation
1 secondary outcome
Hospital and Intensive care length of stay
Time frame: within 30 post-operative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- 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.
- Background: PubMed 36891072Cundrle I Jr, Merta Z, Bratova M, Homolka P, Mitas L, Sramek V, Svoboda M, Chovanec Z, Chobola M, Olson LJ, Brat K. The risk of post-operative pulmonary complications in lung resection candidates with normal forced expiratory volume in 1 s and diffusing capacity of the lung for carbon monoxide: a prospective multicentre study. ERJ Open Res. 2023 Mar 6;9(2):00421-2022. doi: 10.1183/23120541.00421-2022. eCollection 2023 Mar.
- Background: PubMed 32085879Mann J, Williams M, Wilson J, Yates D, Harrison A, Doherty P, Davies S. Exercise-induced myocardial dysfunction detected by cardiopulmonary exercise testing is associated with increased risk of mortality in major oncological colorectal surgery. Br J Anaesth. 2020 Apr;124(4):473-479. doi: 10.1016/j.bja.2019.12.043. Epub 2020 Feb 19.
- Background: PubMed 22560968Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.
- 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 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.
- Individual participant dataSharing planned: Undecided. Information will be provided upon reasonable request.
Related trials for Postoperative Complications
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
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.
Ivan Cundrle, prof., M.D. principal investigator
St. Anne's University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by St. Anne's University Hospital Brno, Czech Republic at 2 sites 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: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Cundrle, prof., M.D. (00420 543182553, Ivan.Cundrle@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pulmonary complications (time frame: within 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 NCT06702059, which also lists 6 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 15 May 2025.