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Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

ConditionSkull Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorIstituto Giannina Gaslini

About this trial

The aim of this clinical trial is to compare musculoskeletal ultrasound with the reference standard diagnostic test (cranial CT scan) in patients with minor head trauma associated with scalp hematoma and suspected skull fracture. The primary objective is to assess the diagnostic accuracy of point-of-care ultrasound in detecting skull fractures, in terms of sensitivity, specificity, positive and negative predictive values, and likelihood ratios, using cranial CT as the reference standard.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

6 years of age or less at enrollment

Blunt head trauma with skull haematoma

Glasgow Coma Scale (GCS) >= 14

signature of the informed consent form

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Skull ultrasound

    Diagnostic test

    Skull point-of-care ultrasound

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients with minor head trauma associated with scalp hematoma and suspected skull fractureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sensibility

Sensibility of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)

Time frame
Baseline, prior to Computed Tomography of the head
2

Specificity

Specificity of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)

Time frame
Baseline, prior to Computed Tomography scan of the head
3

Positive predictive value

Positive predictive value of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan of the head)

Time frame
Baseline, prior to Computed Tomography scan of the head
4

Negative predictive value

Negative predictive value of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan of the head)

Time frame
Baseline, prior to Computed Tomography scan of the head

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Giannina Gaslini

Lead sponsor

Source ClinicalTrials.gov
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