Hemodynamic InstabilityNCT07538115
Advanced vs Standard Hemodynamic Monitoring During Propofol Sedation for ERCP: A Prospective Study
A study testing Hemodynamic Monitoring and Standard Monitoring in people with Hemodynamic Instability, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Hemodynamic Monitoring and Standard Monitoring
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit university
Çorum
Ozgur Yagan, Professor
About this study
Official title: Comparison of Advanced Hemodynamic Monitoring With Standard Monitoring During Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography Procedures: A Randomized Controlled Trial
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.
- Conditions
- Hemodynamic Instability
- Being tested
- Hemodynamic Monitoring, Standard Monitoring
- Keywords
- Advenced hemodynamic Monitorization, ERCP, Sedation, Propofol, Non-operating room anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic MonitoringDevice
Advanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation.
Standard MonitoringProcedure or surgery
Standard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Arm Title: Standard Monitoring Group | Active comparator | 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. Receives: Procedure: Standard Monitoring |
| Arm 2 Arm Title: Advanced Hemodynamic Monitoring Group | Experimental | 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. Receives: Device: Hemodynamic Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the start of sedation until the end of the ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Onen Ozdemir, Hitit University
- Investigators
- Ozgur Yagan, Professor, Study chair, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538115
- Sponsor's protocol ID
- 2026-04
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No