About this trial
The aim of this study is to evaluate whether there is a difference in hemodynamic events requiring intervention between patients monitored with advanced hemodynamic monitoring using the MostCare system and those monitored with standard monitoring alone during propofol sedation for ERCP procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
Patients with an ASA physical status score of III or higher scheduled for ERCP
Patients maintaining spontaneous respiration
Patients who have provided written informed consent
Disqualifiers
Patients requiring general anesthesia
Patients requiring mechanical ventilation
Patients unsuitable for arterial catheterization due to coagulopathy or local infection
Pregnant women
Trial design
Parallel
Treatments tested in this trial
Hemodynamic Monitoring
DeviceAdvanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation.
Standard Monitoring
Procedure/SurgeryStandard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation
Treatment groups
Trial outcomes
Primary outcomes
Number of hemodynamic events requiring clinical intervention during ERCP under propofol sedation
Hemodynamic events requiring intervention, including hypotension (MAP \<65 mmHg), bradycardia (HR \<50 bpm), hypoxemia (SpO₂ \<92%), or sedation-depth abnormalities requiring treatment adjustment, will be recorded and compared between groups
Sponsors and contacts
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