Clinical trial NCT06702059: Cardiopulmonary Exercise Testing in Cardiosurgery Patients
Official title: Cardiopulmonary Exercise Testing in the Prediction of Post-operative Complications in Patients Undergoing Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Keywords: cardiovascular surgery
cardiopulmonary exercise testing
post-operative complications
Lead sponsor: St. Anne's University Hospital Brno, Czech Republic
Sponsor class: OTHER
Collaborators: name: Centre of Cardiovascular and Transplantation Surgery, Czech Republic
First posted: 2024-11-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for coronary artery bypass graft surgery

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: post-operative pulmonary complications
timeFrame: within 30 post-operative days
measure: post-operative cardiovascular complications
timeFrame: within 30 post-operative days
Secondary outcomes:
measure: Hospital and Intensive care length of stay
timeFrame: within 30 post-operative days
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Centre of Cardiovascular and Transplantation Surgery
state: Czech Republic
city: Brno
country: Czechia
facility: St. Anne's University Hospital in Brno
state: Czech Republic
Study officials:
affiliation: St. Anne's University Hospital
name: Ivan Cundrle, prof., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.