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RecruitingNCT07538115Updated Jun 24, 2026

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

An interventional study of Hemodynamic Monitoring and Standard Monitoring in Hemodynamic Instability, sponsored by Hitit University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Hitit University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemodynamic Instability

Keywords

  • Advenced hemodynamic Monitorization
  • ERCP
  • Sedation
  • Propofol
  • Non-operating room anesthesia
03

In context

Lead sponsor

Hitit University is the lead sponsor of 79 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Active comparator
    Arm 1 Arm Title: Standard Monitoring Group

    Patients allocated to the standard monitoring group will receive routine monitoring during ERCP sedation, including non-invasive blood pressure, electrocardiography, peripheral oxygen saturation, and bispectral index monitoring. Sedation will be provided with midazolam and propofol according to the study protocol.

    Procedure: Standard Monitoring

  • Experimental
    Arm 2 Arm Title: Advanced Hemodynamic Monitoring Group

    Patients allocated to the advanced hemodynamic monitoring group will receive standard monitoring plus advanced hemodynamic monitoring using arterial waveform analysis during ERCP sedation. Advanced hemodynamic parameters such as cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, and cardiac cycle efficiency will be recorded and used for hemodynamic assessment.

    Device: Hemodynamic Monitoring

Interventions

  • DeviceHemodynamic Monitoring

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

  • ProcedureStandard Monitoring

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

06

What researchers measure

Primary outcomes

  1. 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

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

07

Study locations

1 of 1 sites recruiting
  • Hitit university
    Çorum, Turkey (Türkiye)
    • Ozgur Yagan, Professor · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07538115
Lead sponsor
Hitit University
Responsible party
Sibel Onen Ozdemir (Medical Doctor, Hitit University) — Principal investigator
First posted
Apr 20, 2026
Start date
Mar 27, 2026
Primary completion
Apr 25, 2026
Completion
Jul 15, 2026 (estimated)
Last update
Jun 24, 2026

Study contacts

Sibel Onen Ozdemir, MD
Contact
sibelonen89@gmail.com
+905442892194
Ozgur Yagan, Professor
study chair · Hitit University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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