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临床试验/NCT07538115
NCT07538115招募中不适用

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

Hitit University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
32
试验地点
1
主要终点
Number of hemodynamic events requiring clinical intervention during ERCP under propofol sedation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

Due to the nature of the monitoring interventions, the attending anesthesiologist cannot be blinded to group allocation. Outcome assessors may be blinded during data extraction and statistical analysis when feasible.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Onen Ozdemir

Medical Doctor

Hitit University

研究点 (1)

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