InfraScanner 2000 for Traumatic Brain Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new technology called the InfraScanner 2000, which uses a special light to detect bleeding in the head after an injury. The goal is to determine if it works as effectively as standard CT scans, without exposing patients to radiation. The trial seeks to make head injury assessments safer and easier, particularly for children with potential head trauma. It is especially suitable for children already undergoing a CT scan due to a suspected head injury. As an unphased trial, it provides a unique opportunity to contribute to safer diagnostic methods for children.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the InfraScanner 2000 is safe for detecting traumatic brain injury?
Research has shown that the InfraScanner 2000 is safe for use. Studies have found that this handheld device can detect brain bleeding without causing harm. The InfraScanner 2000 uses a special light to identify brain bleeding, offering a safer alternative to a CT scan since it doesn't use radiation. Users have not reported any serious side effects, making it a safe choice for identifying brain injuries. Overall, the InfraScanner 2000 appears to be a promising and safe tool for assessing head injuries.12345
Why are researchers excited about this trial?
The InfraScanner 2000 is unique because it uses near-infrared technology to detect hematomas in the brain quickly and non-invasively. Unlike standard CT scans, which are the typical go-to for identifying brain injuries, the InfraScanner 2000 can be used bedside and delivers results almost instantly. Researchers are excited about this device because it could allow for faster diagnosis and treatment of traumatic brain injuries, potentially improving patient outcomes by reducing the time to critical care.
What evidence suggests that the InfraScanner 2000 is effective for detecting traumatic brain injury?
Research shows that the InfraScanner 2000 is promising for detecting bleeding inside the skull caused by head injuries. Studies have demonstrated its effectiveness in identifying bleeding without the need for a CT scan, the usual method. In this trial, all participants will undergo cranial scanning with the InfraScanner 2000 within 4 hours before or after a CT scan. The device accurately detects bleeding and confirms its absence. It uses near-infrared light to examine the brain and has proven especially helpful in emergency situations. Early results suggest it could be a valuable tool, particularly in areas where CT scans are difficult to access.24567
Who Is on the Research Team?
Shobhan Vachhrajani, MD, PhD
Principal Investigator
Dayton Children's Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Participants undergo NIRS scanning using the Infrascanner 2000 within 4 hours before or after a CT scan
Analysis
Data from NIRS and CT scans are analyzed to determine sensitivity, specificity, and predictive values
Follow-up
Participants are monitored for any adverse effects and the integration of NIRS into the emergency department workflow is evaluated
What Are the Treatments Tested in This Trial?
Interventions
- InfraScanner 2000
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dayton Children's Hospital
Lead Sponsor