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

Intracranial Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149082
• Other study ID #: 14-010812
• Status: Completed
• Start date: June 2014
• Est. completion date: September 2018

Study information

• Verified date: November 2018
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hematoma
• Intracranial Hematoma

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Boston Children’s Hospital, Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specificity and Predictive Values of NIRS Measurement	Determine the specificity, as well as positive and negative predictive values of the NIRS measurement for detecting intracranial hematomas	2-years
Secondary	Variability in Sensitivity and Specificity Based on Hematoma Characteristics	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	2-years
Secondary	Age Varying Sensitivity	Determine whether the sensitivity of the NIRS measurement differs by patient age.	2-years