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

November 5, 2018 updated by: Children's Hospital of Philadelphia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
465

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2-years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
2-years
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
2-years
Age Varying Sensitivity
Time Frame: 2-years
Determine whether the sensitivity of the NIRS measurement differs by patient age.
2-years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital Colorado
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Kirschen, MD, PhD, Children's Hospital of Philadelphia

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-010812

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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