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NCT Number: NCT07538115

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hitit university

Çorum, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ozgur Yagan, Professor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemodynamic Monitoring

Device

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

Standard Monitoring

Procedure

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

Primary outcomes

  1. Number of hemodynamic events requiring clinical intervention during ERCP under propofol sedation

    Time frame: From the start of sedation until the end of the ERCP procedure

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sibel Onen Ozdemir, MD

CONTACT

[email protected]

+905442892194

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

Comparison of Advanced Hemodynamic Monitoring With Standard Monitoring During Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography Procedures: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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