- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06702059
Cardiopulmonary Exercise Testing in Cardiosurgery Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ivan Cundrle, prof., M.D.
- Phone Number: 00420 543182553
- Email: Ivan.Cundrle@fnusa.cz
Study Contact Backup
- Name: Marek Lukes, M.D.
- Phone Number: 00 420 543 182 484
- Email: marek.lukes@cktch.cz
Study Locations
-
-
Czech Republic
-
Brno, Czech Republic, Czechia, 60200
- Recruiting
- Centre of Cardiovascular and Transplantation Surgery
-
Contact:
- Marek Lukes, M.D.
- Phone Number: 00 420 543 182 484
- Email: mare.lukes@fnusa.cz
-
Sub-Investigator:
- Petr Fila, M.D., Ph.D.
-
Sub-Investigator:
- Marek Sebo, M.D.
-
Principal Investigator:
- Marek Lukes, M.D.
-
Brno, Czech Republic, Czechia, 61200
- Active, not recruiting
- St. Anne's University Hospital in Brno
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients scheduled for coronary artery bypass graft surgery
Exclusion Criteria:
- not able to perform cardiopulmonary exercise testing, off-pump revascularization, without full sternotomy, previous cardiac surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
coronary artery bypass graft candidates
patients scheduled for CABG surgery will undergo pre-operative cardiopulmonary exercise testing and post-operative complications monitoring
|
Subjects will undergo pre-operative cardiopulmonary exercise testing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-operative pulmonary complications
Time Frame: within 30 post-operative days
|
pneumonia, atelectasis, respiratory failure, ARDS
|
within 30 post-operative days
|
|
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
|
within 30 post-operative days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital and Intensive care length of stay
Time Frame: within 30 post-operative days
|
Hospital and Intensive care length of stay
|
within 30 post-operative days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ivan Cundrle, prof., M.D., St. Anne's University Hospital
Publications and helpful links
General Publications
- Brunelli 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.
- 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.
- 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.
- 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.
- Cundrle 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.
- Mann 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46/2024/OD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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