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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03905031
Other study ID # 2019-002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 15, 2019
Est. completion date May 2025

Study information

Verified date March 2023
Source Dayton Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Patients that present to Dayton Children's Hospital with a head CT order for suspected TBI will be approached for enrollment. An alert will notify study personnel as CT scans are ordered. The goal is to obtain NIRS data within four-hours before or after the CT scan. Informed consent will be obtained according to institutional protocols. NIRS data will be obtained using Infrascanner model 2000 (Infrascanner Inc.). Eight data points will be collected for each subject in standard fashion from right to left frontal, temporal, parietal, and occipital locations. Study personnel will be trained by the manufacturer and will be blinded to the results of the CT scan. Data stored on the Infrascanner will be subsequently transferred to a password-protected database for storage and analysis. For each participant scanned with the Infrascanner 2000, they will be de-identified with a subject number, with patient demographics, mechanism of injury, GCS presentation, time of CT scan, and time of NIRS recorded. CT scan results comprise presence of epidural hematoma and/or subdural hematoma and its maximal thickness if present; presence of intraparenchymal hematoma; presence of skull fracture; and any other traumatic injuries contained in the CT scan report. The length of time required to acquire NIRS data will also be recorded for quality improvement purposes. The specific aims of this study are to better understand the epidemiology of traumatic brain injury (TBI) at Dayton Children's Hospital, to establish the operating characteristics of NIRS for suspected traumatic intracranial hemorrhage at Dayton Children's Hospital, and to study the implementation of a new diagnostic modality in a busy tertiary care emergency department.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - 0-18 years old - Glasgow Coma Score (GCS) 3-15 - Undergoing head CT scan for suspected TBI Exclusion Criteria: - Post-operative patients

Study Design


Intervention

Device:
InfraScanner 2000
The InfraScanner is a portable screening device that measures lateralized differences in optical density (OD) to determine the presence of intracranial hematoma. A difference in OD>0.2 is abnormal and suggestive of intracranial hematoma.

Locations

Country Name City State
United States Dayton Children's Hospital Dayton Ohio

Sponsors (1)

Lead Sponsor Collaborator
Dayton Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of NIRS Optical Density 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 suspected traumatic brain injury compared to head CT scans as the gold standard. Within 4 hours before or after CT scan
Primary Specificity of NIRS Optical Density Measurement Determine the specificity of the NIRS optical density measurement by the Infrascanner device for identifying the presence of intracranial hematomas in pediatric patients after suspected traumatic brain injury compared to head CT scans as the gold standard. Within 4 hours before or after CT scan
Primary Predictive Values of NIRS Measurement Determine the positive and negative predictive values of the NIRS measurements for detecting intracranial hematomas. Within 4 hours before or after CT scan
Secondary Implementation of NIRS in Emergency Department Workflow NIRS integration into patient care workflow will be measured by surveying those involved in NIRS data acquisition monthly, as well as conducting interviews and focus groups. 1 year
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