AnesthesiaNCT06548373
Assessment of Diagnostic Adequacy of AI-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees
An observational study of Anesthesia, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Artificial Intelligence-assisted Point-of-Care Echocardiography
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to Dec 2027
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes Loma Linda University 2024 - 2025 Post-Graduate Year 2 Anesthesiology residents providing anesthetic care.
Who may be able to join
- Loma Linda University resident in Anesthesiology
- Post-Graduate Year 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Troesch Medical Center
Loma Linda, California, 92354
About this study
Official title: Assessment of Diagnostic Adequacy of Artificial Intelligence-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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Artificial Intelligence-assisted Point-of-Care Echocardiography
- Keywords
- echocardiography, Artificial Intelligence, AI-assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-assisted Point-of-Care EchocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Year 2 Residents | Loma Linda University Post-Graduate Year 2 Anesthesiology residents providing anesthetic care. Receives: Diagnostic Test: Artificial Intelligence-assisted Point-of-Care Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours of AI-guided examination completion
Secondary outcomes (2)
Change in length of time of AI-assisted echocardiogram procedure
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.
Measured: 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
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.
Measured: Change in time between the tenth AI-guided echocardiography examination performed and the non-AI guided cardiography examination performed, typically two months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start13 Aug 2024
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard L Applegate, MD, Study chair, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548373
- Sponsor's protocol ID
- IRB 5240271
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22481561Kratz 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.
PubMed 28089598Staudt 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.
PubMed 29916865Via 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.
PubMed 24951446Shillcutt 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.
PubMed 22226417
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Diagnostic Adequacy of Artificial Intelligence-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees
- ClinicalTrials.gov ID
- NCT06548373
- Acronym / sponsor ID
- IRB 5240271
- Conditions
- Anesthesia
- Keywords
- echocardiography, Artificial Intelligence, AI-assisted
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Aug 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Year 2 Residents | – | Diagnostic Test: Artificial Intelligence-assisted Point-of-Care EchocardiographyLoma Linda University Post-Graduate Year 2 Anesthesiology residents providing anesthetic care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes Loma Linda University 2024 - 2025 Post-Graduate Year 2 Anesthesiology residents providing anesthetic care.
Key inclusion criteria (2 listed)
- Loma Linda University resident in Anesthesiology
- Post-Graduate Year 2
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Artificial Intelligence-assisted Point-of-Care EchocardiographyA 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. | Diagnostic test | Year 2 Residents |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 22481561Hofer 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.
- Background: PubMed 28089598Kratz 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.
- Background: PubMed 29916865Staudt 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.
- Background: PubMed 24951446Via 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.
- Background: PubMed 22226417Shillcutt 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.
- Individual participant dataSharing planned: No
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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.
Richard L Applegate, MD study chair
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Loma Linda University at 1 site in United States.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 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 United States. 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?
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?
Echocardiogram Evaluation (time frame: Within 24 hours of AI-guided examination completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06548373, which also lists 5 linked publications.
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 5 Jun 2026.