A Study of the Time to Diagnosis by Hand-held Abdominal Ultrasound in In-patient Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- Time to diagnostic imaging
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- 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.
Exclusion Criteria
- •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.
Arms & Interventions
Handheld Ultrasound/POCUS Arm
Intervention: Portable Ultrasound (Diagnostic Test)
Control Arm
Outcomes
Primary Outcomes
Time to diagnostic imaging
Time Frame: 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).
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.
Secondary Outcomes
- 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).)