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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary: A key decision point in the management of patients with an acute traumatic brain injury is determining the presence of an intracranial hematoma that may require neurosurgical intervention. An expanding hematoma can lead to significant neurological morbidity or death due to brainstem compression or further ischemic injury. Unfortunately, no single physical sign, symptom, or score reliably indicates the presence of an intracranial hematoma. A computerized tomography (CT) scan of the head is the gold standard for emergent identification and localization of acute intracranial hematomas. However, the ionizing radiation from CT scans is associated with an increased risk of developing malignancies. Near infrared spectroscopy (NIRS) is a non-invasive technology that may be useful as an adjunctive modality to CT scanning for early identification of intracranial hematomas. A hand-held NIRS device called the Infrascanner has shown about 90% sensitivity and specificity for detecting intracranial hematomas in adults and a few small studies have shown similar results in children. The present study will aim to validate this device in a wide age range of pediatric subjects and in multiple hospital settings where this device may serve as a valuable screening tool.
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Sensitivity of NIRS Optical Density (OD) Measurement [ Time Frame: 2-years ]

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


Original Primary Outcome:

Current Secondary Outcome:

  • Specificity and Predictive Values of NIRS Measurement [ Time Frame: 2-years ]
    Determine the specificity, as well as positive and negative predictive values of the NIRS measurement for detecting intracranial hematomas
  • Variability in Sensitivity and Specificity Based on Hematoma Characteristics [ Time Frame: 2-years ]
    Determine whether sensitivity and specificity vary depending on hematoma type (i.e. epidural, subdural, subarachnoid, intracerebral), hematoma volume, distance of hematoma from brain surface, and skull thickness
  • Age Varying Sensitivity [ Time Frame: 2-years ]
    Determine whether the sensitivity of the NIRS measurement differs by patient age.


Original Secondary Outcome:

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: May 20, 2014
Date Started: June 2014
Date Completion: May 2017
Last Updated: July 25, 2016
Last Verified: July 2016