Defining the Operating Characteristics of NIRS in the Diagnosis of Pediatric Traumatic Intracranial Hemorrhage

Traumatic Brain Injury Clinical Trial

Official title:

Defining The Operating Characteristics of Near-Infrared Spectroscopy (NIRS) in The Diagnosis of Pediatric Traumatic Intracranial Hemorrhage

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03905031
• Other study ID #: 2019-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: May 2025

Study information

• Verified date: March 2023
• Source: Dayton Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 0-18 years old

• Glasgow Coma Score (GCS) 3-15

• Undergoing head CT scan for suspected TBI

Exclusion Criteria:

• Post-operative patients

Related Conditions & MeSH terms

• Brain Hemorrhage, Traumatic
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Injuries
• Craniocerebral Trauma
• Head Injuries
• Head Injury, Minor
• Head Trauma
• Hematoma
• Hematoma of Head
• Hemorrhage
• Intracranial Hemorrhage, Traumatic
• Intracranial Hemorrhages
• Traumatic Brain Hemorrhage
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• InfraScanner 2000
The InfraScanner is a portable screening device that measures lateralized differences in optical density (OD) to determine the presence of intracranial hematoma. A difference in OD>0.2 is abnormal and suggestive of intracranial hematoma.

Locations

Country	Name	City	State
United States	Dayton Children's Hospital	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Dayton Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of NIRS Optical Density 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 suspected traumatic brain injury compared to head CT scans as the gold standard.	Within 4 hours before or after CT scan
Primary	Specificity of NIRS Optical Density Measurement	Determine the specificity of the NIRS optical density measurement by the Infrascanner device for identifying the presence of intracranial hematomas in pediatric patients after suspected traumatic brain injury compared to head CT scans as the gold standard.	Within 4 hours before or after CT scan
Primary	Predictive Values of NIRS Measurement	Determine the positive and negative predictive values of the NIRS measurements for detecting intracranial hematomas.	Within 4 hours before or after CT scan
Secondary	Implementation of NIRS in Emergency Department Workflow	NIRS integration into patient care workflow will be measured by surveying those involved in NIRS data acquisition monthly, as well as conducting interviews and focus groups.	1 year