InfraScanner 2000 for Traumatic Brain Injury

Overseen By Madelyn Hill, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dayton Children's Hospital

Disqualifiers: Post-operative patients

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

400 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, investigators look at a different type of technology that might help to avoid having to perform CT scans in certain patients suspected of having a head injury. Near-infrared spectroscopy (NIRS) uses a specific light wavelength to determine if there is bleeding into the head as a result of trauma. Investigators will study NIRS, using a device called the Infrascanner model 2000, to determine if it is as good at detecting bleeding in the head as CT scan, which is the current gold standard. Investigators will try to determine if NIRS can rule in or rule out bleeding into the head, and perhaps this can help to avoid subjecting these youth to the potentially harmful effects of radiation. Investigators will also study how easy it is to use NIRS so that it might become a standard part of the workup for children with suspected head injury.

Research Team

Shobhan Vachhrajani, MD, PhD

Principal Investigator

Dayton Children's Hospital

Eligibility Criteria

This trial is for children and teenagers aged 0-18 who are suspected to have a traumatic brain injury (TBI) and are about to get a CT scan. They must be conscious with varying levels of responsiveness, as measured by the Glasgow Coma Score between 3-15. Children who've had recent surgery aren't eligible.

Inclusion Criteria

You have a Glasgow Coma Score between 3 and 15.

I am 18 years old or younger.

You are currently getting a head CT scan because a doctor thinks you might have a head injury.

Exclusion Criteria

I have had surgery related to my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Data Collection

Participants undergo NIRS scanning using the Infrascanner 2000 within 4 hours before or after a CT scan

1 day

1 visit (in-person)

Analysis

Data from NIRS and CT scans are analyzed to determine sensitivity, specificity, and predictive values

4 weeks

Follow-up

Participants are monitored for any adverse effects and the integration of NIRS into the emergency department workflow is evaluated

1 year

Treatment Details

Interventions

• InfraScanner 2000

Trial Overview The study is testing the Infrascanner model 2000, which uses near-infrared spectroscopy (NIRS) technology to detect bleeding in the brain after an injury. It aims to see if NIRS can match or replace CT scans in diagnosing head trauma without exposing young patients to radiation.

Participant Groups

Group I: InfraScanner 2000 Experimental Treatment 1 Intervention

All participants entered into the study will undergo at least one cranial scanning using the InfraScanner 2000 within 4 hours before or after CT scan. Patients will know the results of the CT scan but not of the InfraScanner 2000. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative.

Who Is Running the Clinical Trial?

Dayton Children's Hospital

Lead Sponsor

Trials

13

Recruited

5,029,000+