UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057102 |
|---|---|
| Receipt number | R000065238 |
| Scientific Title | Impact of Real-Time AI Guidance on Image Acquisition Time in Resident Physicians Performing Point-of-Care Ultrasound: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2025/02/21 |
| Last modified on | 2026/08/23 14:39:33 |
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Basic information
Public title
The impact of real-rime AI guidance on Point-of-Care Ultrasound examinations performed by residents
Acronym
The impact of real-rime AI guidance on Point-of-Care Ultrasound examinations performed by residents
Scientific Title
Impact of Real-Time AI Guidance on Image Acquisition Time in Resident Physicians Performing Point-of-Care Ultrasound: A Randomized Crossover Trial
Scientific Title:Acronym
Impact of Real-Time AI Guidance on Image Acquisition Time in Resident Physicians Performing Point-of-Care Ultrasound: A Randomized Crossover Trial
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Cardiology | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of real-time AI assistance on image acquisition time and educational effectiveness in resident physicians performing point-of-care ultrasound (POCUS) examinations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to image acquisition for five standard echocardiographic views recommended by the POCUS guideline in Japan: PLAX, PSAX-PM, AP4, SubC4, and SubC-IVC.
Key secondary outcomes
Time to image acquisition for all ten standard echocardiographic views, including the five views used for the primary outcome plus the following five views: PSAX-AV, PSAX-MV, AP5, AP3 and AP2.
The quality of acquired images.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Prior to the initiation of this study, all participating resident physicians will be administered a brief lecture by an emergency medicine specialist.
Resident physicians will perform echocardiographic examinations with AI assistance.
Interventions/Control_2
Prior to the initiation of the study, all participating resident physicians will be administered a brief lecture by an emergency medicine specialist.
Resident physicians will perform echocardiographic examinations without any AI assistance.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical Qualification: a junior resident
A beginner in ultrasound with 1-2 years of experience
Have basic cardiac ultrasound knowledge
Key exclusion criteria
Prior formal training in echocardiography
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Shinato |
Organization
Sugita Genpaku Memorial Obama Municipal Hospital
Division name
Emergency and general medical department
Zip code
917-8567
Address
2-2 oote-cho, obama-shi, Fukui-ken 917-8567 Japan
TEL
0770-52-0990
doctor.s.u.t@icloud.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Shinato |
Organization
Sugita Genpaku Memorial Obama Municipal Hospital
Division name
Emergency and general medical department
Zip code
917-8567
Address
2-2 oote-cho, obama-shi, Fukui-ken 917-8567 Japan
TEL
0770-52-0990
Homepage URL
doctor.s.u.t@icloud.com
Sponsor or person
Institute
Fukui prefectural hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Fukui prefecural hospital
Address
2-8-1 yotui, fukui-shi, Fukui-ken, Japan
Tel
0776-54-5151
doctor.s.u.t@icloud.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
UMIN000057102
Publication of results
Unpublished
Result
URL related to results and publications
https://data.mendeley.com/preview/t7kn5hv44h?a=4038d8f9-8f0b-4c8a-9a91-7320a4190098
Number of participants that the trial has enrolled
21
Results
Total acquisition time for the five basic views did not differ significantly between the AI-assisted and unassisted conditions (192.9 vs. 125.0 seconds; mean difference [unassisted minus AI-assisted], -67.9 seconds; 95% CI, -138.7 to 2.9; P = 0.058). No significant differences were observed in acquisition time or success rate for any individual basic view.
Results date posted
| 2026 | Year | 08 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Two residents were excluded from the analyses because their ultrasound clips were not saved according to the protocol, leaving 19 participants for analysis. Of these, 16 (84%) were male, 11 were postgraduate year (PGY) 1 residents, and eight were PGY-2 residents. None had previous experience with AI-assisted ultrasonography. Ten participants were assigned to the AI-assisted-first sequence and nine to the unassisted-first sequence; all received the allocated interventions.
Participant flow
A total of 21 residents were enrolled and assigned to either the AI-assisted-first sequence (n = 10) or the unassisted-first sequence (n = 11). Two participants in the unassisted-first sequence were excluded from the analyses because their ultrasound images were not saved according to the protocol. Thus, 19 participants were included in the final analyses: 10 in the AI-assisted-first sequence and nine in the unassisted-first sequence.
Adverse events
None.
Outcome measures
The primary outcomes were the total acquisition time for five basic FoCUS views (SUM5: PLAX, PSAX-PM, A4C, SubC4, and SubC-IVC) and the acquisition success rate for each view. The secondary outcomes were the total acquisition time (SUM10) and acquisition success rates for 10 views, comprising the five basic views plus PSAX-AV, PSAX-MV, A5C, A3C, and A2C. Self-reported confidence in image acquisition was also assessed using pre- and post-trial questionnaires.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065238
