- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149082
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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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
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 |
Intervention / Treatment |
---|---|
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.
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The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of NIRS Optical Density (OD) Measurement
Time Frame: 2-years
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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
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2-years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specificity and Predictive Values of NIRS Measurement
Time Frame: 2-years
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Determine the specificity, as well as positive and negative predictive values of the NIRS measurement for detecting intracranial hematomas
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2-years
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Variability in Sensitivity and Specificity Based on Hematoma Characteristics
Time Frame: 2-years
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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
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2-years
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Age Varying Sensitivity
Time Frame: 2-years
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Determine whether the sensitivity of the NIRS measurement differs by patient age.
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2-years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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
June 1, 2014
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
May 20, 2014
First Submitted That Met QC Criteria
May 23, 2014
First Posted (Estimate)
May 29, 2014
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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