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Recruiting NCT07538115

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

No phase Interventional Hemodynamic Instability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hemodynamic Monitoring, Standard Monitoring.
Who it may be relevant to
Registry conditions: Hemodynamic Instability. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Device Hemodynamic Monitoring
    Advanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation.
  • Procedure Standard Monitoring
    Standard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Hitit university — Çorum

Identifiers

NCT: NCT07538115 · 2026-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗