Clinical trial NCT03905031: Defining the Operating Characteristics of NIRS in the Diagnosis of Pediatric Traumatic Intracranial Hemorrhage
Official title: Defining The Operating Characteristics of Near-Infrared Spectroscopy (NIRS) in The Diagnosis of Pediatric Traumatic Intracranial Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craniocerebral Injuries
Head Injuries
Head Injury, Minor
Head Trauma
Traumatic Brain Injury
Traumatic Brain Hemorrhage
Hematoma of Head
Intracranial Hemorrhages
Keywords: Trauma
Traumatic Brain Injury
Infrascanner
Near-Infrared Spectroscopy
Pediatric
Lead sponsor: Dayton Children's Hospital
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In this study, investigators look at a different type of technology that might help to avoid having to perform CT scans in certain patients suspected of having a head injury. Near-infrared spectroscopy (NIRS) uses a specific light wavelength to determine if there is bleeding into the head as a result of trauma. Investigators will study NIRS, using a device called the Infrascanner model 2000, to determine if it is as good at detecting bleeding in the head as CT scan, which is the current gold standard. Investigators will try to determine if NIRS can rule in or rule out bleeding into the head, and perhaps this can help to avoid subjecting these youth to the potentially harmful effects of radiation. Investigators will also study how easy it is to use NIRS so that it might become a standard part of the workup for children with suspected head injury.

Detailed description: Patients that present to Dayton Children's Hospital with a head CT order for suspected TBI will be approached for enrollment. An alert will notify study personnel as CT scans are ordered. The goal is to obtain NIRS data within four-hours before or after the CT scan. Informed consent will be obtained according to institutional protocols. NIRS data will be obtained using Infrascanner model 2000 (Infrascanner Inc.). Eight data points will be collected for each subject in standard fashion from right to left frontal, temporal, parietal, and occipital locations. Study personnel will be trained by the manufacturer and will be blinded to the results of the CT scan. Data stored on the Infrascanner will be subsequently transferred to a password-protected database for storage and analysis. For each participant scanned with the Infrascanner 2000, they will be de-identified with a subject number, with patient demographics, mechanism of injury, GCS presentation, time of CT scan, and time of NIRS recorded. CT scan results comprise presence of epidural hematoma and/or subdural hematoma and its maximal thickness if present; presence of intraparenchymal hematoma; presence of skull fracture; and any other traumatic injuries contained in the CT scan report. The length of time required to acquire NIRS data will also be recorded for quality improvement purposes.

The specific aims of this study are to better understand the epidemiology of traumatic brain injury (TBI) at Dayton Children's Hospital, to establish the operating characteristics of NIRS for suspected traumatic intracranial hemorrhage at Dayton Children's Hospital, and to study the implementation of a new diagnostic modality in a busy tertiary care emergency department.

Eligibility criteria: Inclusion Criteria:

* 0-18 years old
* Glasgow Coma Score (GCS) 3-15
* Undergoing head CT scan for suspected TBI

Exclusion Criteria:

* Post-operative patients

Primary outcomes:
measure: Sensitivity of NIRS Optical Density Measurement
timeFrame: Within 4 hours before or after CT scan
measure: Specificity of NIRS Optical Density Measurement
timeFrame: Within 4 hours before or after CT scan
measure: Predictive Values of NIRS Measurement
timeFrame: Within 4 hours before or after CT scan
Secondary outcomes:
measure: Implementation of NIRS in Emergency Department Workflow
timeFrame: 1 year
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
Study officials:
affiliation: Dayton Children's Hospital
name: Shobhan Vachhrajani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: