A study of the optic nerve sheath diameter to predict Intracranial Hypertension in Pediatric Brain Injured Patients

Study ID
STU 042016-041

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Cynthia Greenwell
913/620-2626
cynthia.greenwell@childrens.com

Principal Investigator
Darryl Miles, M.D.

Summary

once iRB approved, written/verbal consent obtained, this prospective observational study will collect age based data in two cohorts: normative data from children without brain pathology and study who will have direct iCP measurements as part of their standard of care. will be measured using the Sonosite edge ultrasound device already in use at Children's Health Dallas. We will use the FDa approved ophthalmologic settings for measuring the onSD from outpatient, emergency department, and inpatient units treating children from infancy to 18 years of age. For the younger and uncooperative children, we will coordinate measuring the onSD when the patients are already sedated for another procedure. The sedation may have an impact on the iCP readings, but the onSD will be performed under the same sedation conditions as the invasive method used to obtain iCP readings. Positioning for all patients will include lying flat, or elevated head of bed to 30 degrees, with the head midline allowing the patient's focus to be straight ahead. To obtain normative data, the cohort of patients that have no brain injury will be seen prior to undergoing standard of care procedures, such as a lumbar puncture, a ventriculostomy or a brain procedure where intracranial Pressure (iCP) will be measured. noTe: usually opening cerebral spinal pressures are obtained when patients have Lumbar Punctures, but depending on the purpose of Lumbar puncture the opening pressure might not be measured. The study team will not ask for this to be done and the patient will not be asked to participate in this study. if the measurement is obtained, the study team will access the medical record for this result and correlate it to the study ultrasound if the patient decides to be part of this study. The provider will know and inform the study team, if the subject's procedure will or will not include that opening intracranial pressure reading. The goal for normative data accrual is 64 per age group, up to 192 normal children (those with no brain injury) and two separate onSD examiners will perform the onSD procedure sequentially to determine test reliability. once all normative data is collected, the patient's with brain injury will be added. The patient study population, the second cohort, will have the same study accrual goal, of 64 per age group-total 192. The Pi and his summer Medical Student, Kelsey Kirkman who is credentialed at Children's Health, will be performing the study procedure. also once trained, Dr. Tonia Sabo will be performing the study procedure. This non-invasive technique could significantly improve the quality of care delivered with this vulnerable pediatric population.

Participant Eligibility

2 study cohorts upon signing of consent. for the normative data: Children in stratified age groups ages less than 1 yr old, 1 - less than or equal to 4yrs old, older than years old. Goal of 64 per age group (192 total). [STRATIFIED AGE GROUPS ARE IN THE CHANGES TO BETTER INDICATE POSSIBLE AGE LIMITATIONS THAT COULD AFFECT THE FINDINGS IN BOTH THE NORMATIVE DATASET AND PATIENT DATASET]
For the second study dataset: Children 0-18 yrs old, stratified age groups less than 1 year old, 1 - less than or equal to 4 years old, older than 4 years old, a study goal of 64 per age group (192 total) of pediatric patients with a neurological condition and a device placed to measure ICP as part of their standard of care. For the younger children that might be uncooperative, the ONSD will be performed prior to the invasive method to measure the ICP. Similarly, the ONSD is performed on the pediatric patient while waiting for a procedure or surgery and without delaying or interrupting the standard of care. [AN EXAMPLE OF WHEN A NORMATIVE DATASET PATIENT WOULD BE A GOOD CANDIDATE IS BETTER EXPLAINED-THE STUDY PROCEDURE CAN BE DONE WHEN THEY ARE WAITING FOR A PROCEDURE BUT ARE ALREADY UNDER SEDATION FOR THE PROCEDURE TO BEGIN AND ONLY IF PREVIOUS CONSENT WAS OBTAINED-WITH MORE THAN ONE MEASUREMENT FOR EACH PATIENT NO MATTER WHICH DATASET IS INVOLVED]