Clinical trial NCT02149082: Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children
Official title: Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hematoma
Keywords: Intracranial hematoma
traumatic brain injury
Near infrared spectroscopy
NIRS
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Children's Hospital Colorado
First posted: 2014-05-29
Enrollment: 465
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Department (ED), Pediatric Intensive Care Unit (PICU)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Males or females ≤18 years admitted to the Children's Hospital of Philadelphia (CHOP) ED or PICU with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence of an intracranial hematoma.
* Head injury occurred \<12 hours prior to presentation for the initial CT scan, or the subject had a clinical change prompting repeat CT scanning.

Exclusion Criteria:

* Evidence of extensive scalp injury including lacerations, avulsions, or abrasions that will impair proper coupling of the Infrascanner device to the subject's head or prevent placement of the device in the specified locations.
* History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.

Primary outcomes:
measure: Sensitivity of NIRS Optical Density (OD) Measurement
timeFrame: 2-years
Secondary outcomes:
measure: Specificity and Predictive Values of NIRS Measurement
timeFrame: 2-years
measure: Variability in Sensitivity and Specificity Based on Hematoma Characteristics
timeFrame: 2-years
measure: Age Varying Sensitivity
timeFrame: 2-years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Matthew Kirschen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: