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

NCT03905031 | Unknown FDA Device

• 1 other identifier: 2019-002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Implementation of NIRS in Emergency Department Workflow

  1 year

Study Arms (1)

InfraScanner 2000

EXPERIMENTAL

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

Interventions

InfraScanner 2000 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.

InfraScanner 2000

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Post-operative patients

Sponsors & Collaborators

• Dayton Children's Hospital: lead

Study Sites (1)

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic; Brain Hemorrhage, Traumatic; Intracranial Hemorrhages; Wounds and Injuries

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Intracranial Hemorrhage, Traumatic; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shobhan Vachhrajani, MD, PhD

  Dayton Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgical Research

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 5, 2019
• Study Start: April 15, 2019
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)