Actively Recruiting

Age: 18Years +
All Genders
ID07538115

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

Led by Hitit University · Updated on 2026-06-05

32

Participants Needed

1

Research Sites

11 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to compare advanced hemodynamic monitoring with standard monitoring during propofol sedation for ERCP procedures, focusing on whether advanced monitoring better detects hemodynamic events needing intervention. ERCP is used mainly for therapeutic treatment of biliary and pancreatic duct disorders, especially in elderly patients who often face hemodynamic challenges during sedation due to comorbidities. Maintaining adequate organ blood flow and oxygen is crucial, and standard monitoring may miss some important hemodynamic changes. The study has two groups: one group receives standard monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS without arterial cannulation. The other group receives advanced monitoring using the MostCare system via radial arterial cannulation, capturing detailed parameters like cardiac output, stroke volume, systemic vascular resistance, and cardiac power output. Both groups undergo ERCP under propofol sedation, with advanced monitoring aimed at providing more detailed data to guide interventions. Participants will be adults aged 18 or older with certain physical health status undergoing ERCP while breathing on their own. They will be monitored from the start of sedation until the end of the procedure for hemodynamic events requiring clinical intervention. The study will record the number of such events and compare findings between the two monitoring methods. Consent and continuous monitoring ensure participant safety throughout the procedure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring During ERCP Procedure

Duration - Duration of the ERCP procedure (typically a few hours)

Participants undergo ERCP under propofol sedation with either standard monitoring or advanced hemodynamic monitoring using the MostCare system. Standard monitoring includes non-invasive blood pressure, ECG, pulse oximetry, and BIS. Advanced monitoring involves additional radial arterial cannulation and continuous hemodynamic assessment.

1 procedure visit (in-person)

Trial Site Locations

Total: 1 location

1

Hitit university

Çorum, Turkey (Türkiye)

Actively Recruiting

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Research Team

S

Sibel Onen Ozdemir, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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