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 21 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
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 completion21 Oct 2026
- Study completion21 Oct 2026
Why it stopped: The study was terminated due to technical and logistical limitations
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 (actual)
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
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Advanced Hemodynamic Monitoring With Standard Monitoring During Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography Procedures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07538115
- Acronym / sponsor ID
- 2026-04
- Conditions
- Hemodynamic Instability
- Keywords
- Advenced hemodynamic Monitorization, ERCP, Sedation, Propofol, Non-operating room anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to technical and logistical limitations
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 21 Oct 2026 (actual)
- Study completion
- 21 Oct 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Arm Title: Standard Monitoring Group | Active comparator | Procedure: Standard MonitoringPatients 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. |
| Arm 2 Arm Title: Advanced Hemodynamic Monitoring Group | Experimental | Device: Hemodynamic MonitoringPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic MonitoringAdvanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation. | Device | Arm 2 Arm Title: Advanced Hemodynamic Monitoring Group |
| Standard MonitoringStandard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation | Procedure or surgery | Arm 1 Arm Title: Standard Monitoring Group |
Primary outcome
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
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
Results and safety
The study was stopped early (reason given: The study was terminated due to technical and logistical limitations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for Hemodynamic Instability
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozgur Yagan, Professor study chair
Hitit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamic Monitoring and Standard Monitoring in people with Hemodynamic Instability, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to technical and logistical limitations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.