Diagnostic Accuracy and Operational Efficiency of Point-of-Care Ultrasound (POCUS) in Long Bone Fractures: A Brazilian Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 260
- Primary Endpoint
- Sensitivity of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
Study Overview
Brief Summary
The purpose of this study is to evaluate the diagnostic accuracy and operational efficiency of Point-of-Care Ultrasound (POCUS) for identifying long bone fractures in the emergency department.
Traditionally, suspected long bone fractures are diagnosed using X-rays. While effective, X-rays require transporting patients to a radiology suite, involve exposure to ionizing radiation, and can contribute to longer emergency room wait times. POCUS is a portable, radiation-free imaging tool that physicians perform directly at the patient's bedside. The investigators hypothesize that POCUS can accurately identify or rule out long bone fractures when compared to standard X-rays, and that its use will reduce the time required to make clinical decisions.
This is a multicenter, prospective observational study. Participants arriving at the emergency department with a suspected long bone fracture will undergo a bedside ultrasound examination performed by a trained emergency physician. Following the ultrasound, all participants will receive standard-of-care X-ray imaging.
Researchers will compare the initial POCUS findings to the final X-ray results (the reference standard) to determine the sensitivity and specificity of the ultrasound. Additionally, the study will measure operational timelines-including time to diagnosis, time to treatment decision, and total length of stay in the emergency department-to assess the impact of POCUS on hospital workflow and patient care efficiency.
Detailed Description
## Background and Rationale
Long bone fractures are among the most frequent traumatic injuries managed in emergency departments (EDs) worldwide. The current standard of care for diagnosing these fractures is plain radiography (X-ray). While highly effective and widely available, the standard radiological workflow presents several challenges in crowded ED environments. It requires patient transport to a radiology suite-which can exacerbate pain in trauma patients-involves exposure to ionizing radiation, and often contributes to significant delays in clinical decision-making and overall length of stay (LOS).
Point-of-Care Ultrasound (POCUS) has emerged as a rapid, portable, and radiation-free imaging modality that can be performed directly at the patient's bedside. Previous single-center studies have suggested that POCUS has high sensitivity and specificity for detecting fractures. However, there is a lack of robust, multicenter data evaluating its real-world implementation in diverse Brazilian emergency settings. The POCUS-BONE BR study aims to fill this gap by assessing both the diagnostic accuracy and the operational impact of integrating musculoskeletal POCUS into the standard trauma workflow.
## Study Objectives
**Primary Objective:** To determine the diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of bedside POCUS performed by emergency physicians for the detection of long bone fractures, using standard plain radiography as the reference standard.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 years or older;
- •Presenting with clinical suspicion of a long bone fracture (pain, deformity, swelling, or functional limitation);
- •Provision of informed consent (signed Informed Consent Form - ICF).
Exclusion Criteria
- •Patients with open fractures;
- •Hemodynamic instability (resuscitation priority);
- •Known previous fractures in the same bone segment;
- •Need for immediate surgical intervention;
- •Refusal to participate.
Outcomes
Primary Outcomes
Sensitivity of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
Time Frame: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours.
Sensitivity is the percentage of participants with a long bone fracture confirmed by the reference standard (conventional radiography independently interpreted by a blinded radiologist) who were correctly classified as having a fracture by point-of-care ultrasound (POCUS) performed by a trained emergency physician. Sensitivity is calculated as the number of true positive POCUS examinations divided by the total number of participants with a fracture on the reference standard, multiplied by 100. Reported as a percentage with a 95 percent confidence interval.
Secondary Outcomes
- Interobserver Agreement Between Point-of-Care Ultrasound (POCUS) Operators(From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours)
- Positive Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures(From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours)
- Negative Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures(From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours)
- Overall Diagnostic Accuracy of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures(From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours)
- Time From Emergency Department Arrival to Point-of-Care Ultrasound (POCUS) Result(From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours)
- Time From Emergency Department Arrival to Radiography Report Availability(From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours)
- Emergency Department Length of Stay(From emergency department arrival to emergency department discharge, assessed up to 72 hours)
Investigators
Emanuel Ayrton Balanga
Emergency Medicine Resident
University of Sao Paulo