Diagnostic Accuracy and Operational Efficiency of Point-of-Care Ultrasound (POCUS) in Long Bone Fractures: A Brazilian Multicenter Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients with open fractures;

Hemodynamic instability (resuscitation priority);

Known previous fractures in the same bone segment;

Need for immediate surgical intervention;

Trial population

The study population consists of adult patients (18 years of age or older) presenting to the emergency departments of two major Brazilian academic hospitals: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) and Hospital das Clínicas da Faculdade de Medicina de Marília (HCFAMEMA). Eligible participants are those seeking care for acute extremity trauma with clinical suspicion of a long bone fracture, characterized by signs such as localized pain, visible deformity, swelling, or functional limitation. Patients presenting with open fractures, hemodynamic instability requiring immediate resuscitation, known previous fractures in the same anatomical segment, or those requiring immediate surgical intervention are excluded from this study population.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

260 Participants
are grouped into 2 trial groups
Group A: Arm A
Group B: Arm B

Trial outcomes

Primary outcomes

1

Sensitivity of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

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.

Time frame
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours.

Secondary outcomes

1

Positive Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

Positive predictive value is the percentage of participants with a positive point-of-care ultrasound (POCUS) examination who have a long bone fracture confirmed by the reference standard (conventional radiography independently interpreted by a blinded radiologist). It is calculated as the number of true positive POCUS examinations divided by the total number of positive POCUS examinations, multiplied by 100. Reported as a percentage with a 95 percent confidence interval.

Time frame
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
2

Negative Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

Negative predictive value is the percentage of participants with a negative point-of-care ultrasound (POCUS) examination who have no long bone fracture on the reference standard (conventional radiography independently interpreted by a blinded radiologist). It is calculated as the number of true negative POCUS examinations divided by the total number of negative POCUS examinations, multiplied by 100. Reported as a percentage with a 95 percent confidence interval.

Time frame
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
3

Overall Diagnostic Accuracy of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures

Overall diagnostic accuracy is the percentage of participants correctly classified by point-of-care ultrasound (POCUS), calculated as the sum of true positive and true negative POCUS examinations divided by the total number of participants assessed, multiplied by 100. The reference standard is conventional radiography independently interpreted by a blinded radiologist. Reported as a percentage with a 95 percent confidence interval.

Time frame
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
4

Interobserver Agreement Between Point-of-Care Ultrasound (POCUS) Operators

Agreement between two independent point-of-care ultrasound (POCUS) operators regarding the presence or absence of a long bone fracture, measured by the Cohen kappa coefficient. Kappa values range from -1 to 1, where 1 indicates perfect agreement, 0 indicates agreement equivalent to chance, and negative values indicate agreement worse than chance. Reported as a kappa coefficient with a 95 percent confidence interval.

Time frame
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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