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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05900440
Other study ID # IRB-42094
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date June 30, 2026

Study information

Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether artificial intelligence systems improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning with artificial intelligence vs devices with no artificial intelligence. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and performance on quizzes.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date June 30, 2026
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Internal medicine residents rotating on the general inpatient wards service. Exclusion Criteria: - Residents who had taken an ultrasound elective offered by our residency program

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ultrasound with Artificial Inteligence Engabled
Participants shall be randomized 1:1 to receive personal access to a handheld ultrasound device with artificial intelligence vs a device with no artificial intelligence. The groups shall not cross over in which intervention they received.
Ultrasound without Artificial Intelligence Enabled
Participants shall be randomized 1:1 to receive personal access to a handheld ultrasound device with artificial intelligence vs a device with no artificial intelligence. The groups shall not cross over in which intervention they received.

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kumar A, Weng Y, Wang L, Bentley J, Almli M, Hom J, Witteles R, Ahuja N, Kugler J. Portable Ultrasound Device Usage and Learning Outcomes Among Internal Medicine Trainees: A Parallel-Group Randomized Trial. J Hosp Med. 2020 Feb 11;15(2):e1-e6. doi: 10.12788/jhm.3351. Online ahead of print. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to acquire cardiac ultrasound images This will be measured as the time to acquire a cardiac ultrasound image on a standardized patient, measured in seconds. During procedure (300 seconds)
Secondary Assessment of the quality of captured images Participants will acquire cardiac ultrasound images on a standardized patient. Two reviewers will review the images and provide a numerical assessment of image quality based on the Rapid Assessment for Competency in Echocardiography (RACE) Scale. This is a 0-20 point scale, with higher scores denoting higher image quality (e.g. a better quality image). During procedure (300 seconds)
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