NCT06548373

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

August 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 13, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

August 7, 2024

Last Update Submit

January 28, 2026

Conditions

Keywords

echocardiographyArtificial IntelligenceAI-assisted

Outcome Measures

Primary Outcomes (1)

  • Echocardiogram Evaluation

    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.

    Within 24 hours of AI-guided examination completion

Secondary Outcomes (2)

  • Change in length of time of AI-assisted echocardiogram procedure

    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

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

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

Study Arms (1)

Year 2 Residents

Loma Linda University Post-Graduate Year 2 Anesthesiology residents providing anesthetic care.

Diagnostic Test: Artificial Intelligence-assisted Point-of-Care Echocardiography

Interventions

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.

Year 2 Residents

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes Loma Linda University 2024 - 2025 Post-Graduate Year 2 Anesthesiology residents providing anesthetic care.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Troesch Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (5)

  • Hofer CK, Mizuguchi AK, Popescu WM. Monitoring the patient at risk of hemodynamic instability in remote locations. Int Anesthesiol Clin. 2012 Spring;50(2):141-72. doi: 10.1097/AIA.0b013e318250ebb1. No abstract available.

    PMID: 22481561BACKGROUND
  • Kratz T, Steinfeldt T, Exner M, Dell Orto MC, Timmesfeld N, Kratz C, Skrodzki M, Wulf H, Zoremba M. Impact of Focused Intraoperative Transthoracic Echocardiography by Anesthesiologists on Management in Hemodynamically Unstable High-Risk Noncardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):602-609. doi: 10.1053/j.jvca.2016.11.002. Epub 2016 Nov 2.

    PMID: 28089598BACKGROUND
  • Staudt GE, Shelton K. Development of a Rescue Echocardiography Protocol for Noncardiac Surgery Patients. Anesth Analg. 2019 Aug;129(2):e37-e40. doi: 10.1213/ANE.0000000000003569.

    PMID: 29916865BACKGROUND
  • Via G, Hussain A, Wells M, Reardon R, ElBarbary M, Noble VE, Tsung JW, Neskovic AN, Price S, Oren-Grinberg A, Liteplo A, Cordioli R, Naqvi N, Rola P, Poelaert J, Gulic TG, Sloth E, Labovitz A, Kimura B, Breitkreutz R, Masani N, Bowra J, Talmor D, Guarracino F, Goudie A, Xiaoting W, Chawla R, Galderisi M, Blaivas M, Petrovic T, Storti E, Neri L, Melniker L; International Liaison Committee on Focused Cardiac UltraSound (ILC-FoCUS); International Conference on Focused Cardiac UltraSound (IC-FoCUS). International evidence-based recommendations for focused cardiac ultrasound. J Am Soc Echocardiogr. 2014 Jul;27(7):683.e1-683.e33. doi: 10.1016/j.echo.2014.05.001.

    PMID: 24951446BACKGROUND
  • Shillcutt SK, Markin NW, Montzingo CR, Brakke TR. Use of rapid "rescue" perioperative echocardiography to improve outcomes after hemodynamic instability in noncardiac surgical patients. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):362-70. doi: 10.1053/j.jvca.2011.09.029. Epub 2012 Jan 4.

    PMID: 22226417BACKGROUND

Study Officials

  • Richard L Applegate, MD

    Loma Linda University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 12, 2024

Study Start

August 13, 2024

Primary Completion

April 28, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations