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

NCT ID: NCT03905031

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2025-05-31

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.

Conditions

Craniocerebral Injuries; Head Injuries; Head Injury, Minor; Head Trauma; Traumatic Brain Injury; Traumatic Brain Hemorrhage; Hematoma of Head; Intracranial Hemorrhages

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

InfraScanner 2000

All participants entered into the study will undergo at least one cranial scanning using the InfraScanner 2000 within 4 hours before or after CT scan. Patients will know the results of the CT scan but not of the InfraScanner 2000. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative.

Group Type: EXPERIMENTAL

InfraScanner 2000

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dayton Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shobhan Vachhrajani, MD, PhD, FRCSC

Director of Surgical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shobhan Vachhrajani, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dayton Children's Hospital

Locations

Dayton Children's Hospital

Dayton, Ohio, United States

Countries

United States

Other Identifiers

2019-002

Identifier Type: -

Identifier Source: org_study_id