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Hemodynamic InstabilityNCT06828575

Evaluation of the Success of Artificial Intelligence Models in Interpreting Arterial Waveform Analysis Data

An observational study of Hemodynamic Instability, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to evaluate the ability of artificial intelligence (AI) models to interpret arterial waveform analysis data obtained from a hemodynamic monitoring system in adult patients undergoing elective surgery. 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?
predictions
How many people
145 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2025to 16 Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: This study will include adult patients (≥18 years old) undergoing elective surgery requiring intraoperative arterial waveform monitoring as part of routine perioperative care. The population will consist of patients from two tertiary-level hospitals where advanced hemodynamic monitoring with the MostCare system is regularly utilized. Participants will be selected based on their eligibility for continuous arterial pressure monitoring, ensuring a standardized dataset for AI analysis. The study population will represent a diverse range of surgical procedures, including but not limited to: General surgery (e.g., abdominal, hepatobiliary, colorectal procedures)

Who may be able to join

  • Age ≥ 18 years
  • Undergoing elective surgery with arterial waveform monitoring as part of standard perioperative care
  • Hemodynamic data successfully recorded using the MostCare hemodynamic monitoring system
  • Able to provide informed consent to participate in the study

Who cannot join

  • Incomplete or corrupted hemodynamic data (e.g., signal artifacts preventing reliable analysis)
  • Emergency surgery cases
  • Patients with severe arrhythmias or hemodynamic instability that might interfere with arterial waveform interpretation
  • Refusal to participate or withdrawal of consent
  • Patients with contraindications to arterial catheterization (e.g., coagulopathy, severe peripheral vascular disease)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Engin ihsan Turan, Specialist contact

05382431114

enginihsan@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    Istanbul, 34303

    Engin ihsan Turan, 05382431114, enginihsan@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

The goal of this observational study is to evaluate the ability of artificial intelligence (AI) models to interpret arterial waveform analysis data obtained from a hemodynamic monitoring system in adult patients undergoing elective surgery. The main questions it aims to answer are:

Can AI models (ChatGPT-4 and Gemini 2.0) accurately detect hemodynamic abnormalities in arterial waveform data? How well do AI-generated diagnoses align with expert anesthesiologist assessments? Are AI-generated treatment recommendations clinically appropriate?

Read more

Participants will:

Undergo standard hemodynamic monitoring with an arterial waveform analysis device (MostCare).

Have their anonymized hemodynamic data analyzed by AI models for abnormality detection, diagnosis suggestions, and treatment recommendations.

Have AI-generated results reviewed and validated by experienced anesthesiologists.

This study aims to assess whether AI models can serve as decision-support tools in perioperative and critical care settings by improving the interpretation of complex hemodynamic data, potentially enhancing patient safety, diagnostic accuracy, and clinical efficiency.

Read the detailed description

This prospective observational study aims to evaluate the ability of artificial intelligence (AI) models to interpret arterial waveform analysis data obtained from a hemodynamic monitoring system. The study will focus on assessing the accuracy of ChatGPT-4 and Gemini 2.0 in detecting hemodynamic abnormalities, providing diagnostic suggestions, and offering treatment recommendations based on arterial waveform data collected from elective surgical patients.

Background and Rationale Arterial waveform analysis is a critical component of advanced hemodynamic monitoring, providing real-time insights into cardiac output, vascular resistance, and volume status. These parameters are essential for guiding perioperative fluid management and optimizing hemodynamic stability in surgical and critically ill patients. While automated monitoring systems generate large amounts of data, the interpretation of these waveforms remains dependent on clinician expertise. The integration of AI-based decision-support tools in this context could enhance real-time clinical decision-making and reduce workload for healthcare providers.

Study Objectives

The primary objective of this study is to determine the ability of AI models to analyze arterial waveform data and detect clinically significant hemodynamic abnormalities. The secondary objectives are:

To assess the concordance between AI-generated diagnoses and expert anesthesiologist assessments.

To evaluate the clinical appropriateness of AI-generated treatment recommendations.

To explore the potential role of AI in clinical decision support systems for hemodynamic monitoring.

Study Design and Methodology

This study will be conducted at two tertiary-level healthcare institutions:

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital Başakşehir Çam and Sakura City Hospital The study will include adult patients undergoing elective surgery who require intraoperative arterial waveform monitoring as part of routine perioperative care.

Data Collection Process Hemodynamic data will be collected from participants using the MostCare hemodynamic monitoring system, which is routinely used in perioperative settings.

Data collection will take place at three time points:

Pre-anesthesia (baseline hemodynamic status before induction) Post-anesthesia induction (after intubation, before surgical incision) Intraoperative period (during key surgical events requiring hemodynamic intervention) If an intervention needs according to arterial wave analysis we will also take data before and after intervention.

AI-Based Analysis

The collected arterial waveform data will be anonymized and processed by AI models (ChatGPT-4 and Gemini 2.0) to provide:

Abnormality detection - Identifying any deviations from normal hemodynamic parameters.

Diagnostic suggestions - Providing likely clinical diagnoses based on the waveform patterns.

Treatment recommendations - Suggesting possible interventions to optimize hemodynamic status.

Expert Validation AI-generated results will be independently reviewed by experienced anesthesiologists to assess their accuracy and clinical relevance.

The concordance between AI outputs and expert assessments will be statistically analyzed.

Outcome Measures

Primary Outcome:

Accuracy of AI models in detecting hemodynamic abnormalities compared to expert assessments.

Secondary Outcomes:

Concordance between AI-generated diagnoses and anesthesiologist diagnoses. Clinical appropriateness of AI-generated treatment recommendations compared to standard clinical practice.

AI models' potential role in enhancing clinical decision-making in perioperative hemodynamic management.

Ethical Considerations The study does not involve any additional interventions beyond routine clinical monitoring.

No patient-identifiable data will be used in AI model analysis. Informed consent will be obtained from all participants before enrollment. The study has been approved by the relevant ethics committees at both participating institutions.

Study Timeline Planned study duration: 6 months Estimated start date: February 15, 2025 Estimated completion date: August 15, 2025 Potential Impact

This study will provide valuable insights into the role of AI in automated hemodynamic monitoring and perioperative decision support. If successful, AI-driven analysis of arterial waveform data could:

Enhance patient safety through early detection of hemodynamic abnormalities. Improve efficiency by assisting anesthesiologists in data interpretation. Reduce workload for perioperative and critical care teams. Support future AI-based clinical decision-support tools for hemodynamic monitoring.

Being tested
predictions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • predictionsOther

    predictions of learning language models

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy

    Accuracy of AI models in detecting hemodynamic abnormalities (True or False).

    Measured: 1 day

Secondary outcomes (2)
  1. Concordance Between AI-Generated Diagnoses and Expert Anesthesiologist Diagnoses

    AI-generated diagnostic suggestions will be compared with the final diagnosis made by anesthesiologists (True or False).

    Measured: 1 DAY

  2. Clinical Appropriateness of AI-Generated Treatment Recommendations

    The relevance and accuracy of AI-suggested treatments will be evaluated against standard clinical management (True or False).

    Measured: 1 DAY

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start15 Feb 2025
  3. Primary completion15 Aug 2025 (estimated)
  4. Study completion16 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828575
Sponsor's protocol ID
mostcare
Status last verified
Mar 2025
First submitted
10 Feb 2025
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hemodynamic Instability, run by Kanuni Sultan Suleyman Training and Research Hospital 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: looking for participants now, as of the sponsor's last update on 4 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Engin ihsan Turan, Specialist (05382431114, enginihsan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy (time frame: 1 day). 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 4 Mar 2025.

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