Anesthesia, Cardiac Arrythmias
Conditions
Keywords
catheter ablation, anesthesiology, conscious Sedation, deep sedation, hemodynamic monitoring
Brief summary
This prospective observational clinical study aims to evaluate the clinical utility of Pressure Recording Analytical Method (PRAM)-based minimally invasive hemodynamic monitoring in patients undergoing cardiac ablation procedures. The study will be conducted in the cardiac catheterization laboratory of Istanbul University-Cerrahpaşa Cardiology Institute and will include 27 adult patients scheduled for catheter ablation. Written informed consent will be obtained from all participants, and the study will adhere to the principles of the Declaration of Helsinki.
Detailed description
Cardiac ablation procedures performed in electrophysiology laboratories are increasingly complex and frequently conducted under non-operating room anesthesia (NORA). These procedures carry a risk of hemodynamic instability due to arrhythmia induction, procedural manipulation, and potential complications such as cardiac tamponade, thromboembolism, or fluid overload. Continuous and accurate hemodynamic monitoring is therefore essential for optimal patient management. However, data on the use of minimally invasive hemodynamic monitoring techniques in this setting remain limited. This prospective observational clinical study aims to evaluate the clinical utility of Pressure Recording Analytical Method (PRAM)-based minimally invasive hemodynamic monitoring in patients undergoing cardiac ablation procedures. The study will be conducted in the cardiac catheterization laboratory of Istanbul University-Cerrahpaşa Cardiology Institute and will include 27 adult patients scheduled for catheter ablation. Written informed consent will be obtained from all participants, and the study will adhere to the principles of the Declaration of Helsinki. All patients will undergo standard monitoring, including electrocardiography, heart rate, pulse oximetry, and invasive arterial blood pressure measurement via radial or femoral arterial access. In addition, continuous beat-to-beat hemodynamic data will be obtained using the MostCare® system, which applies the PRAM algorithm for real-time waveform analysis. Primary hemodynamic parameters include heart rate, systolic, diastolic, and mean arterial pressures. Advanced parameters such as stroke volume, cardiac output, cardiac index, systemic vascular resistance, stroke volume variation, pulse pressure variation, dP/dt max, and cardiac cycle efficiency will also be recorded. Measurements will be collected at three predefined time points: before ablation (T0), during ablation (T1), and after ablation (T2). The primary objective is to assess time-dependent changes in hemodynamic parameters and evaluate the contribution of PRAM-based monitoring to intra-procedural patient management. Secondary aims include generating evidence to support anesthesiologists' clinical decision-making and contributing to the development of future guidelines for high-risk NORA settings. Statistical analysis will be performed using repeated measures methods, with a significance level set at p\<0.05.
Interventions
Continuous beat-to-beat hemodynamic monitoring using the Pressure Recording Analytical Method (PRAM) via an invasive arterial line.
Sponsors
Istanbul University - Cerrahpasa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Age ≥18 years * Patients scheduled for cardiac catheter ablation in the electrophysiology laboratory * Indication for ablation confirmed by a cardiologist * Ability to provide written informed consent * Planned invasive arterial blood pressure monitoring during the procedure
Exclusion criteria
* Refusal or inability to provide informed consent * Failure to identify arrhythmogenic focus leading to cancellation of ablation procedure * Severe hemodynamic instability prior to procedure * Contraindication to invasive arterial catheterization * Incomplete hemodynamic data acquisition * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac Output measured by PRAM during catheter ablation | Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation) | Cardiac output (L/min) measured using the PRAM-based monitoring system during catheter ablation procedures under non-operating room anesthesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stroke Volume During Catheter Ablation | Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation) | Stroke volume (mL/beat) measured using PRAM-based hemodynamic monitoring during the procedure. |
| Change in Mean Arterial Pressure During Catheter Ablation | Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation) | Mean arterial pressure (mmHg) measured invasively and analyzed during the procedure. |
| Change in Systemic Vascular Resistance During Catheter Ablation | Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation) | Systemic vascular resistance (dyn·s/cm⁵) measured using PRAM-based monitoring during catheter ablation. |
| Change in dP/dt max During Catheter Ablation | Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation) | Maximum arterial pressure rise over time (dP/dt max, mmHg/s) measured using PRAM-based analysis. |
| Change in Cardiac Cycle Efficiency During Catheter Ablation | Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation) | Cardiac cycle efficiency (%) assessed using the PRAM-based monitoring system during catheter ablation. |
| Change in Arterial Elastance | Intra-procedural (T0: before ablation, T1: during ablation, T2: after ablation) | Change in arterial elastance derived from PRAM across predefined procedural periods: before, during, and after catheter ablation. Arterial elastance will be expressed as mmHg/mL. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRKerem Erkalp
Istanbul University-Cerrahpasa, Institute of Cardiology
Outcome results
None listed