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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with minor head trauma associated with scalp hematoma and suspected skull fracture | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skull ultrasound | Diagnostic Test | Skull point-of-care ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensibility | Sensibility of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan) | Baseline, prior to Computed Tomography of the head |
| Specificity | Specificity of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan) | Baseline, prior to Computed Tomography scan of the head |
| Positive predictive value | Positive predictive value of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan of the head) | Baseline, prior to Computed Tomography scan of the head |
| Negative predictive value | Negative predictive value of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan of the head) | Baseline, prior to Computed Tomography scan of the head |
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Inclusion Criteria:
Exclusion Criteria:
- Haemodinamic or neurological instability
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo D'Alessandro, MD, PhD | Contact | 3498265535 | +39 | matteodalessandro@gaslini.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Giannina Gaslini Institute | Recruiting | Genova | Italy | 16147 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33273039 | Background | Alexandridis G, Verschuuren EW, Rosendaal AV, Kanhai DA. Evidence base for point-of-care ultrasound (POCUS) for diagnosis of skull fractures in children: a systematic review and meta-analysis. Emerg Med J. 2022 Jan;39(1):30-36. doi: 10.1136/emermed-2020-209887. Epub 2020 Dec 3. | |
| 29698348 | Background | Choi JY, Lim YS, Jang JH, Park WB, Hyun SY, Cho JS. Accuracy of Bedside Ultrasound for the Diagnosis of Skull Fractures in Children Aged 0 to 4 Years. Pediatr Emerg Care. 2020 May;36(5):e268-e273. doi: 10.1097/PEC.0000000000001485. |
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| ID | Term |
|---|---|
| D012887 | Skull Fractures |
| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| ID | Term |
|---|---|
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| 22579023 | Background | Parri N, Crosby BJ, Glass C, Mannelli F, Sforzi I, Schiavone R, Ban KM. Ability of emergency ultrasonography to detect pediatric skull fractures: a prospective, observational study. J Emerg Med. 2013 Jan;44(1):135-41. doi: 10.1016/j.jemermed.2012.02.038. Epub 2012 May 11. |
| D014947 |
| Wounds and Injuries |
| D003933 |
| Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |