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Advanced vs Standard Hemodynamic Monitoring During Propofol Sedation for ERCP: A Prospective Study

Comparison of Advanced Hemodynamic Monitoring With Standard Monitoring During Propofol Sedation in ERCP Procedures: A Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07538115
Enrollment
32
Registered
2026-04-20
Start date
2026-03-27
Completion date
2026-05-15
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

Keywords

Advenced hemodynamic Monitorization, ERCP, Sedation, Propofol, Non-operating room anesthesia

Brief summary

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.

Detailed description

ERCP is a widely used interventional procedure for the visualization and treatment of biliary and pancreatic duct disorders. Compared with surgery, it is less invasive and provides an effective therapeutic alternative. Although its diagnostic use has declined with the increasing availability of less invasive imaging modalities, ERCP is still frequently performed for therapeutic purposes such as relieving biliary or pancreatic obstruction, placing stents, and obtaining tissue samples. The need for ERCP is particularly increasing in elderly patients due to biliary stones and malignant obstruction. In this population, sepsis, hemodynamic fragility, and accompanying comorbidities make anesthesia and sedation management more challenging during the procedure. The primary goal of perioperative hemodynamic management is to maintain adequate organ perfusion and oxygen delivery. Although blood pressure is routinely monitored in clinical practice, parameters such as cardiac output, stroke volume, systemic vascular resistance, and afterload may provide a more comprehensive understanding of the mechanisms underlying hemodynamic status. A normal mean arterial pressure alone does not necessarily indicate adequate cardiac output or tissue perfusion. Therefore, some hemodynamic disturbances may remain undetected in patients assessed with standard monitoring alone. Advanced hemodynamic monitoring methods allow continuous assessment of parameters such as cardiac output, stroke volume, systemic vascular resistance, arterial elastance, and cardiac power output through arterial waveform analysis. The MostCare system, using PRAM technology, can obtain these data from the invasive arterial pressure waveform without requiring external calibration. By providing a more detailed evaluation of the causes of hemodynamic instability, it may facilitate more targeted and timely interventions. The aim of this study is to evaluate whether advanced hemodynamic monitoring with MostCare provides an advantage over standard monitoring alone in the detection and management of hemodynamic events requiring intervention in patients undergoing ERCP under propofol sedation. In addition, the study seeks to clarify the potential clinical contribution of advanced monitoring in interventional procedures performed under sedation.

Interventions

DEVICEHemodynamic Monitoring

Advanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation.

Standard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation

Sponsors

Hitit University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients requiring general anesthesia * Patients requiring mechanical ventilation * Patients unsuitable for arterial catheterization due to coagulopathy or local infection * Pregnant women * Patients who do not sign the informed consent form

Design outcomes

Primary

MeasureTime frameDescription
Number of hemodynamic events requiring clinical intervention during ERCP under propofol sedationFrom the start of sedation until the end of the ERCP procedureHemodynamic 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

Countries

Turkey (Türkiye)

Contacts

CONTACTSibel Onen Ozdemir, MD
sibelonen89@gmail.com+905442892194
STUDY_CHAIROzgur Yagan, Professor

Hitit University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026