Clinical trial NCT06548373: Assessment of Diagnostic Adequacy of AI-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees
Official title: Assessment of Diagnostic Adequacy of Artificial Intelligence-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anesthesia
Keywords: echocardiography
Artificial Intelligence
AI-assisted
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes Loma Linda University 2024 - 2025 Post-Graduate Year 2 Anesthesiology residents providing anesthetic care.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Echocardiogram Evaluation
timeFrame: Within 24 hours of AI-guided examination completion
Secondary outcomes:
measure: Change in length of time of AI-assisted echocardiogram procedure
timeFrame: 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
measure: Change in echocardiogram examination image quality through comparison of AI-guided and non-AI-guided echocardiogram examination
timeFrame: Change in time between the tenth AI-guided echocardiography examination performed and the non-AI guided cardiography examination performed, typically two months post-enrollment
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Troesch Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: Richard L Applegate, MD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.