Cardiopulmonary Exercise Testing in Cardiosurgery Patients

NCT06702059 | Recruiting

• 1 other identifier: 46/2024/OD
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Complications

Keywords

cardiovascular surgery; cardiopulmonary exercise testing; post-operative complications

Outcome Measures

Primary Outcomes (2)

• post-operative pulmonary complications

  pneumonia, atelectasis, respiratory failure, ARDS

  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

  within 30 post-operative days

Secondary Outcomes (1)

• Hospital and Intensive care length of stay

  within 30 post-operative days

Study Arms (1)

coronary artery bypass graft candidates

patients scheduled for CABG surgery will undergo pre-operative cardiopulmonary exercise testing and post-operative complications monitoring

Diagnostic Test: Cardiopulmonary exercise testing

Interventions

Cardiopulmonary exercise testing DIAGNOSTIC_TEST

Subjects will undergo pre-operative cardiopulmonary exercise testing.

coronary artery bypass graft candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for coronary artery bypass graft surgery

You may qualify if:

• patients scheduled for coronary artery bypass graft surgery

You may not qualify if:

• not able to perform cardiopulmonary exercise testing, off-pump revascularization, without full sternotomy, previous cardiac surgery

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Centre of Cardiovascular and Transplantation Surgery, Czech Republic: collaborator

Study Sites (2)

Centre of Cardiovascular and Transplantation Surgery

Brno, Czech Republic, 60200, Czechia

RECRUITING

St. Anne's University Hospital in Brno

Brno, Czech Republic, 61200, Czechia

ACTIVE NOT RECRUITING

Related Publications (6)

• 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.

  PMID: 27496629 BACKGROUND

• 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.

  PMID: 36891072 BACKGROUND

• 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.

  PMID: 32085879 BACKGROUND

• 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.

  PMID: 22560968 BACKGROUND

• 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.

  PMID: 35074321 BACKGROUND

• 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.

  PMID: 17989266 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Ivan Cundrle, prof., M.D.

  St. Anne's University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Cundrle, prof., M.D.

CONTACT

00420 543182553; Ivan.Cundrle@fnusa.cz

Marek Lukes, M.D.

CONTACT

00 420 543 182 484; marek.lukes@cktch.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CZ (2)