Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children

NCT02149082 | Completed DMC

• 1 other identifier: 14-010812
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density (OD) measurement with an Infrascanner device accurately identifies the presence of an intracranial hematoma in pediatric patients ≤18 years of age after known or suspected traumatic brain injury compared with head computerized tomography (CT) scans as the gold standard.

Conditions

Intracranial Hematoma

Keywords

Intracranial hematoma; traumatic brain injury; Near infrared spectroscopy; NIRS

Outcome Measures

Primary Outcomes (1)

• Sensitivity of NIRS Optical Density (OD) 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 known or suspected traumatic brain injury compared to head CT scans as the gold standard

  2-years

Secondary Outcomes (3)

• Specificity and Predictive Values of NIRS Measurement

  2-years

• Variability in Sensitivity and Specificity Based on Hematoma Characteristics

  2-years

• Age Varying Sensitivity

  2-years

Study Arms (1)

Infrascanner exam

Infrascanner Model 2000 exams may be conducted either before or after an associated head CT for pediatric patients presenting to the emergency department (ED) or pediatric intensive care unit (PICU) with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence or absence of an intracranial hematoma. The time between the head CT scan and the Infrascanner exam will be within 6 hours. The exam involves placing a sensor on the designated areas of the head with the most common locations for traumatic hematoma. Readings from the monitor evaluating each region will be evaluated and recorded. The 8-point exam can be accomplished within 5 minutes or less.

Device: Infrascanner Model 2000

Interventions

Infrascanner Model 2000 DEVICE

The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding.

Infrascanner exam

Eligibility Criteria

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

Study Population

Emergency Department (ED), Pediatric Intensive Care Unit (PICU)

You may qualify if:

• Males or females ≤18 years admitted to the Children's Hospital of Philadelphia (CHOP) ED or PICU with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence of an intracranial hematoma.
• Head injury occurred \<12 hours prior to presentation for the initial CT scan, or the subject had a clinical change prompting repeat CT scanning.

You may not qualify if:

• Evidence of extensive scalp injury including lacerations, avulsions, or abrasions that will impair proper coupling of the Infrascanner device to the subject's head or prevent placement of the device in the specified locations.
• History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Boston Children's Hospital: collaborator
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Matthew Kirschen, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 29, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (1)