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

May 7, 2026 updated by: Sibel Onen Ozdemir, Hitit University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Çorum, Turkey (Türkiye)
        • Recruiting
        • Hitit University
        • Contact:
          • Ozgur Yagan, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients with ASA physical status III or higher who are scheduled for elective ERCP and managed under propofol sedation while maintaining spontaneous respiration in a single-center tertiary care university hospital setting.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 - Standard Monitoring Group
In this group, sedation depth will be monitored using non-invasive arterial blood pressure (NIBP), electrocardiography (ECG), pulse oximetry (SpO₂), and BIS. Arterial cannulation and advanced hemodynamic monitoring will not be applied.
Procedure: Standard Monitoring
Standard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation
Group 2 - Advanced Hemodynamic Monitoring Group
In addition to standard monitoring parameters, radial arterial cannulation will be performed, and advanced hemodynamic variables including cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI), systemic vascular resistance and systemic vascular resistance index (SVR), arterial elastance (Ea), cardiac cycle efficiency (CCE), and cardiac power output (CPO) will be monitored using the MostCare system (Vygon, Italy).
Device: Hemodynamic Monitoring
Advanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the start of sedation until the end of the ERCP procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitit University

Investigators

  • Study Chair: Ozgur Yagan, Professor, Hitit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Actual)

April 25, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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