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

March 3, 2023 updated by: Shobhan Vachhrajani, MD, PhD, FRCSC, Dayton Children's Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Dayton, Ohio, United States, 45404
        • Dayton Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Post-operative patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of NIRS Optical Density Measurement
Time Frame: Within 4 hours before or after CT scan
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
Specificity of NIRS Optical Density Measurement
Time Frame: Within 4 hours before or after CT scan
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
Predictive Values of NIRS Measurement
Time Frame: Within 4 hours before or after CT scan
Determine the positive and negative predictive values of the NIRS measurements for detecting intracranial hematomas.
Within 4 hours before or after CT scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation of NIRS in Emergency Department Workflow
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dayton Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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