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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
| Children's Hospital Colorado | OTHER |
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This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density (OD) measurement with an Infrascanner device accurately identifies the presence of an intracranial hematoma in pediatric patients ≤18 years of age after known or suspected traumatic brain injury compared with head computerized tomography (CT) scans as the gold standard.
A key decision point in the management of patients with an acute traumatic brain injury is determining the presence of an intracranial hematoma that may require neurosurgical intervention. An expanding hematoma can lead to significant neurological morbidity or death due to brainstem compression or further ischemic injury. Unfortunately, no single physical sign, symptom, or score reliably indicates the presence of an intracranial hematoma. A computerized tomography (CT) scan of the head is the gold standard for emergent identification and localization of acute intracranial hematomas. However, the ionizing radiation from CT scans is associated with an increased risk of developing malignancies. Near infrared spectroscopy (NIRS) is a non-invasive technology that may be useful as an adjunctive modality to CT scanning for early identification of intracranial hematomas. A hand-held NIRS device called the Infrascanner has shown about 90% sensitivity and specificity for detecting intracranial hematomas in adults and a few small studies have shown similar results in children. The present study will aim to validate this device in a wide age range of pediatric subjects and in multiple hospital settings where this device may serve as a valuable screening tool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infrascanner exam | Infrascanner Model 2000 exams may be conducted either before or after an associated head CT for pediatric patients presenting to the emergency department (ED) or pediatric intensive care unit (PICU) with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence or absence of an intracranial hematoma. The time between the head CT scan and the Infrascanner exam will be within 6 hours. The exam involves placing a sensor on the designated areas of the head with the most common locations for traumatic hematoma. Readings from the monitor evaluating each region will be evaluated and recorded. The 8-point exam can be accomplished within 5 minutes or less. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrascanner Model 2000 | Device | The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of NIRS Optical Density (OD) Measurement | Determine the sensitivity of the NIRS optical density measurement by the Infrascanner device for identifying the presence of intracranial hematomas in pediatric patients after known or suspected traumatic brain injury compared to head CT scans as the gold standard | 2-years |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity and Predictive Values of NIRS Measurement | Determine the specificity, as well as positive and negative predictive values of the NIRS measurement for detecting intracranial hematomas | 2-years |
| Variability in Sensitivity and Specificity Based on Hematoma Characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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Emergency Department (ED), Pediatric Intensive Care Unit (PICU)
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Kirschen, MD, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Determine whether sensitivity and specificity vary depending on hematoma type (i.e. epidural, subdural, subarachnoid, intracerebral), hematoma volume, distance of hematoma from brain surface, and skull thickness |
| 2-years |
| Age Varying Sensitivity | Determine whether the sensitivity of the NIRS measurement differs by patient age. | 2-years |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |