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

NCT07497490 | Completed

• 1 other identifier: 25626
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Diseases

Keywords

Handheld ultrasound; Abdominal diseases; Gastrointestinal and hepatology consultation; In-patient; Hospita length of stay

Outcome Measures

Primary Outcomes (1)

• 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): Defined as the interval from the consultation request to the first modality that established the correct diagnosis of the targeted organs matching the final electronic medical record. If the bedside POCUS findings accurately identified the primary pathology, the POCUS timestamp was used; otherwise, the timestamp of the subsequent formal radiology report was utilized. 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 Outcomes (2)

• Post-Consultation Hospital Length of Stay (LOS)

  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)

  From the time of initial HUD evaluation up to hospital discharge (an average of 2 to 4 weeks).

Study Arms (2)

Handheld Ultrasound/POCUS Arm

EXPERIMENTAL

Diagnostic Test: Portable Ultrasound

Control Arm

NO INTERVENTION

Interventions

Portable Ultrasound DIAGNOSTIC_TEST

A handheld portable ultrasound sponsored by Aco Healthcare Co., Ltd company

Handheld Ultrasound/POCUS Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients aged over 18 who are hospitalized and requiring for a gastroenterology consultation or abdominal ultrasound, including cases of abdominal pain, diarrhea, abnormal liver function, unexplained fever, or evaluating intra-abdominal lesions.

You may not qualify if:

• Patients unable to comply with handheld ultrasound examination.
• Patients who are in the intensive care unit.
• Patients who had already undergone formal abdominal imaging within one week prior to the consultation.
• Patients who referred for immediate endoscopic intervention, such as active gastrointestinal bleeding or foreign body ingestion.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Aco Healthcare Co., Ltd.: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30779825 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: March 27, 2026
• Study Start: December 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: May 31, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)