The Role of Cerebral Oximetry in Pediatric Concussion Assessment

The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Sponsors

Lead Sponsor: Johns Hopkins University

Collaborator: Medtronic - MITG

Source Johns Hopkins University
Brief Summary

The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.

Overall Status Terminated
Start Date January 2014
Completion Date June 30, 2015
Primary Completion Date June 30, 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls. At presentation (Day 0)
Secondary Outcome
Measure Time Frame
Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls. At presentation (Day 0)
Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls. At presentation (Day 0)
Enrollment 59
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

INCLUSION CRITERIA:

All Participants

- Age 10-18 years at time of visit

Concussion Group

- Present to JHH PED within the first 24 hours following trauma.

- Diagnosis of concussion as defined by the 3rd International Conference on Concussion in Sport (McCrory), including the presence of any one or more of the following:

1. Symptoms (ie. headache, neck pain, nausea/vomiting, dizziness, blurred vision, balance problems, sensitive to light, sensitivity to noise, feeling slowed down, feeling in a fog, difficulty concentrating, difficulty remembering, fatigue, confusion, drowsiness, more emotional, irritability, sadness, nervous)

2. Physical Signs (ie. loss of consciousness, unsteadiness)

3. Impaired brain function (ie. confusion)

- Glasgow Coma Score of 13-15 upon arrival to JHH PED.

- Loss of consciousness of less than 15 minutes (if applicable).

- No structural intracranial injuries identified on neuroimaging (if completed).

EXCLUSION CRITERIA

All Participants

- History of prior concussion or traumatic brain injury within preceding 6 weeks.

- History of prior intracranial disease or mass (ie. tumor, intraventricular hemorrhage, etc.)

- Presence of intracranial hardware.

- Complaints of respiratory distress, tachypnea or hypoxia, which may affect regional cerebral oxygen saturation.

- Inability to stand secondary to lower extremity disease or trauma, which is required for completion of SCAT2.

- Inability to complete SCAT2 questionnaire secondary to developmental delay.

- Child in foster care or legal guardian not available.

- Participant known to be pregnant, which alters total body blood flow and likely affects regional cerebral oxygen saturation.

- Non-English speaking.

Gender: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jennifer Anders, MD Principal Investigator Johns Hopkins University
Location
Facility: Johns Hopkins University Pediatric Emergency Medicine
Location Countries

United States

Verification Date

January 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Concussion Group

Label: Control Group

Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov