Advanced versus standard heart and blood-flow monitoring during propofol sedation for ERCP
Comparison of Advanced Hemodynamic Monitoring With Standard Monitoring During Propofol Sedation in ERCP Procedures: A Prospective Observational Study
This study sees if using the MostCare advanced hemodynamic monitor instead of standard monitoring reduces hemodynamic events that need treatment in adults (ASA III+) having propofol sedation for ERCP.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hitit University Academic / other |
| Locations | 1 site (Çorum) |
| Trial ID | NCT07538115 on ClinicalTrials.gov |
What this trial studies
This prospective observational study compares patients monitored with the MostCare advanced hemodynamic system to those receiving standard monitoring alone during propofol sedation for ERCP. Adult patients (≥18 years) with ASA physical status III or higher who maintain spontaneous respiration and consent are included, while those requiring general anesthesia, mechanical ventilation, or who are unsuitable for arterial catheterization are excluded. The primary focus is on hemodynamic events that require intervention, using continuous advanced parameters (cardiac output, stroke volume, systemic vascular resistance) versus routine vital signs. The study is conducted at a single center and documents whether advanced monitoring identifies disturbances missed by standard monitoring.
Who should consider this trial
Good fit: Adults aged 18 or older with ASA III or higher scheduled for ERCP under propofol sedation who maintain spontaneous breathing and can undergo arterial catheterization and give informed consent.
Not a fit: Patients who need general anesthesia or mechanical ventilation, pregnant patients, or those with coagulopathy or local infection that prevent arterial catheterization are unlikely to benefit from this monitoring approach.
Why it matters
Potential benefit: If successful, this could help clinicians detect hidden circulatory problems earlier and reduce blood-pressure–related complications during ERCP sedation.
How similar studies have performed: Advanced hemodynamic monitoring and cardiac-output–guided management have shown benefits in some perioperative settings, but their specific use during ERCP sedation is less well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Çorum
- Hitit university — Çorum, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sibel Onen Ozdemir, MD
- Email: sibelonen89@gmail.com
- Phone: +905442892194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.