A Study of the Time to Diagnosis by Hand-held Abdominal Ultrasound in In-patient Settings

The goal of this study is to investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the impact of hospital length of stay.

Study Overview

• Status: Completed
• Conditions: Abdominal Diseases
• Intervention / Treatment: Diagnostic test: Portable Ultrasound

Detailed Description

The utilization of handheld ultrasound in the diagnosis and treatment of acute diseases has been practiced for many years, and in certain scenarios, its efficacy is comparable to that of traditional ultrasound. The portability and real-time bedside application of handheld ultrasound have made it increasingly significant in the clinical practice of subspecialties such as cardiovascular, thoracic, and hepato- gastroenterology. Consequently, the use of handheld ultrasound during hospitalizations or emergencies may shorten the time required for accurate diagnosis, enabling patients to receive timely treatment.

To investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the commencement of treatment.

This study employs a prospective design with an anticipated enrollment of 200 patients over approximately one year (December 2024 to November 2025). A clustered-randomized controlled trial design will be used to fit real-world clinical scenario, with participants allocated to either an intervention group (current consultation model supplemented with handheld ultrasound) or a control group by odd/even-numbered calendar days. The primary outcome will be the speed of diagnostic imaging between the two groups. Secondary outcomes will include other indicators of inpatient care quality, such as length of hospital stay and diagnostic accuracy.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged over 18 who are hospitalized or in the intensive care unit.
• Those requiring a gastroenterology consultation or abdominal ultrasound, including cases of abdominal pain, diarrhea, abnormal liver function, unexplained fever, or evaluating intra-abdominal vascular thrombosis.

Exclusion Criteria:

- Patients unable to comply with handheld ultrasound examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm
Experimental: Handheld Ultrasound/POCUS Arm	Diagnostic test: Portable Ultrasound; A handheld portable ultrasound sponsored by Aco Healthcare Co., Ltd company

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to diagnostic imaging	This outcome evaluates the clinical efficiency of the diagnostic workflow by measuring the time interval (in minutes) required to complete the initial diagnostic imaging. The exact measurement endpoints are defined by the study arm: Start point (Both arms): The exact time the gastroenterology consultation is initiated. End point (Intervention group): The execution of the point-of-care evaluation using the handheld ultrasound device (HUD) by the consultant at the bedside. End point (Control group): The execution of the first formally scheduled diagnostic imaging study (e.g., computed tomography [CT], magnetic resonance imaging [MRI], or conventional cart-based ultrasound) ordered as part of standard care following the consultation.	From the initiation of the consultation to the execution of the diagnostic imaging study, assessed up to hospital discharge (an average of 14 to 30 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Consultation Hospital Length of Stay (LOS)	This outcome evaluates the impact of the intervention on overall hospital resource utilization by measuring the post-consultation length of stay. The post-consultation LOS is defined as the time interval (measured in days) starting from the exact date the gastroenterology consultation is initiated (baseline) to the date the patient is officially discharged from the hospital. Data will be collected for both the intervention group (HUD) and the control group (standard care). Group differences will be analyzed to determine if the expedited point-of-care diagnostic workflow associated with the intervention effectively reduces the remaining hospitalization days. To account for skewed clinical data, comparisons will be reported using median days with interquartile ranges (IQR) and adjusted rate ratios.	From the initiation of the gastroenterology consultation to the date of hospital discharge, assessed up to a maximum of 1 year.
Diagnostic Accuracy of the Targeted Organ by Handheld Ultrasound Device (HUD)	This outcome evaluates the diagnostic accuracy of the initial point-of-care evaluation using a HUD. Accuracy is determined by comparing HUD findings (Index Test) against the final definitive diagnosis (Reference Standard). Index Test: The primary pathology recorded by the consultant immediately following the bedside HUD examination. Reference Standard: The final clinical diagnosis of the targeted organ (e.g., biliary tract, liver, pancreas) established prior to discharge. This is confirmed by subsequent formal imaging (e.g., comprehensive ultrasound, CT, MRI). Accuracy is reported as the percentage of HUD evaluations correctly matching the reference standard.	From the time of initial HUD evaluation up to hospital discharge (an average of 2 to 4 weeks).

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Aco Healthcare Co., Ltd.

Publications and helpful links

General Publications

• Barreiros AP, Dong Y, Ignee A, Wastl D, Dietrich CF. EchoScopy in scanning abdominal diseases; a prospective single center study. Med Ultrason. 2019 Feb 17;21(1):8-15. doi: 10.11152/mu-1907.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: In-patient; Handheld ultrasound; Abdominal diseases; Gastrointestinal and hepatology consultation; Hospita length of stay
• Other Study ID Numbers: 25626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No