About this trial
During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices. This ECG is analyzed for time, amplitude, and frequency parameters-more than 200 parameters per cardiac cycle. Additionally, the available parameters of a standard 12-lead ECG recording are determined. All parameters of both single-lead and 12-lead ECGs will be included in a multivariate regression analysis to determine the optimal method for predicting atrial fibrillation, life-threatening cardiac arrhythmias, and conduction abnormalities in the perioperative period after high-risk cardiac procedures.
The study will include patients undergoing high-risk cardiac surgeries, such as those on the heart, aorta, esophagus, pancreas, liver, and lungs, as well as high-risk oncological surgeries. A partial analysis will also be performed depending on the type of intervention. Rhythm and conduction disturbances will be recorded during surgery, as well as in the postoperative period, using ECG monitors, 24-hour ECG monitoring, and repeated recordings of a standard ECG when complaints or signs of unstable hemodynamics arise
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age;
Scheduled surgery with high cardiac risk
Informed consent was given to participate in the study
Disqualifiers
Cancellation of the surgery for any reason;
The patient's unwillingness to continue participating in the study;
Poor quality of the ECG recording on a single-channel ECG monitor.
Trial population
The study will analyze patients undergoing elective high-risk cardiac surgeries, including cardiac surgery, aortic surgery, esophageal and gastric cardia surgery, and thoracic surgery. Patients undergoing large-scale oncological surgeries will also be included.
Trial design
Cohort
Prospective
Treatments tested in this trial
digital single-channel ECG recording
Diagnostic testA single-channel ECG will be recorded for 3 minutes while the patient is sitting at rest. The patient leans back against the chair, legs uncrossed, and arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex (CardioQVARK medical device (Electrocardiograph) issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare) P3H 2024/22855, issued on June 5, 2024).
Treatment groups
Trial outcomes
Primary outcomes
specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy
statistical parameter of diagnostic and prognostic accuracy of the method under study
specificity, sensitivity, prognostic significance of a positive and negative result, prognostic significance of a positive and positive result, diagnostic accuracy
statistical parameter of diagnostic and prognostic accuracy of the method under study
Locations
Sponsors and contacts
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