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NCT Number: NCT06548373

Assessment of Diagnostic Adequacy of AI-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees

This pilot study serves to assess the diagnostic adequacy of Artificial Intelligence (AI)-guided point-of-care. Focused echocardiography examinations will be obtained by Anesthesiology trainees and assessed by an expert Cardiologist Echocardiographer. AI-guided echocardiography examinations will be compared to each other. AI-guided and non-AI-guided echocardiography examinations will also be compared.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Troesch Medical Center

Loma Linda, California, 92354, United States

About this study

This pilot study will involve Post-Graduate Year 2 Anesthesiology trainees on rotation in the Loma Linda University Medical Center operating rooms. Prior to participation, the trainees will give written informed consent to participate in the study and complete a baseline questionnaire to collect information regarding prior education in point-of-care echocardiography and the number of those examinations personally performed prior to study participation. All subjects will watch a brief training video about the AI guidance platform and participate in a hands on training session to familiarize themselves with AI guidance.

When adult patients having anesthesia for procedures present with a clinical indication for peri-anesthesia point-of-care echocardiography examination, the assigned trainee will use the AI-guided system to obtain a standardized point-of-care focused cardiac examination. Subjects will be completing 11 total examinations, 10 using AI guidance, 1 without.

Images of the examination will be assessed by an expert Cardiologist Echocardiographer that is blinded to the resident involved to measure diagnostic adequacy.

A final non-AI-guided echocardiogram examination will be completed by the resident to measure and compare the time and adequacy of the images to the AI-guided examination images.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Loma Linda University resident in Anesthesiology
  • Post-Graduate Year 2

Exclusion criteria

  • Residents not a part of a Loma Linda University residency program
  • Residents not a part of an Anesthesiology residency program
  • Loma Linda University Anesthesiology Post-Graduate Year 1 Residents
  • Loma Linda University Anesthesiology Post-Graduate Year 3 Residents
  • Loma Linda University Anesthesiology Post-Graduate Year 4 Residents

Treatment and study plan

Artificial Intelligence-assisted Point-of-Care Echocardiography

Diagnostic Test

A wireless, AI-guided handheld ultrasound probe will be used on adult male patients who present with a clinical indication for peri-anesthesia point-of-care echocardiography examination.

Residents will document personal interpretation of the completed point-of-care ultrasound (POCUS) examination, important clinical findings, and assessment of whether obtaining a formal echocardiogram is warranted on an exam assessment form. The residents will complete 11 examinations with 10 specific scans each. The first 10 examinations will be AI-guided, and the final 11th examination will be done via a standard (non-AI guided) ultrasound system to gauge the resident's growth in point-of-care echocardiography skill.

Primary outcomes

  1. Echocardiogram Evaluation

    Time frame: Within 24 hours of AI-guided examination completion

    Cardiologist will review AI-assisted echocardiogram images obtained by residents for diagnostic image quality. A rating of "Yes" will represent a diagnostically accurate result and a rating of "No" will represent an image that is not adequate for diagnostic purposes.

Secondary outcomes

  1. Change in length of time of AI-assisted echocardiogram procedure

    Time frame: Change in time of individual examination completion between the first AI-guided echocardiography examination performed and the tenth AI-guided echocardiography examination performed, typically one month post-enrollment

    Assessment of time to complete the standardized point-of-care focused echocardiography examination will be determined by comparing time stamps on the first and last image sequence recorded. Change in this interval will be assessed between the tenth and first studies performed.

  2. Change in echocardiogram examination image quality through comparison of AI-guided and non-AI-guided echocardiogram examination

    Time frame: Change in time between the tenth AI-guided echocardiography examination performed and the non-AI guided cardiography examination performed, typically two months post-enrollment

    After the 10th AI-guided point-of-care focused echocardiography examination is completed, the trainee will complete a standardized point-of-care focused echocardiography examination using a standard (not AI-guided) system. Assessment of echocardiogram adequacy, time to complete the examination, and Concordance between the trainee and Cardiologist assessments will be analyzed as described above.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Assessment of Diagnostic Adequacy of Artificial Intelligence-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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