Optic Nerve Sheath Diameter and Intracranial Pressure (ICP) in Children

NCT02507063 | Withdrawn DMC

• 1 other identifier: 15.0326
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised ICP has many potential benefits. This includes having assessments that can be made at the bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove useful in the emergency department (ED) setting in the evaluation of shunts used for cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The investigators further hypothesize that ONSD changes will correlate with changes in ICP, making it a useful bedside tool for assessing ICP changes over time. This is a prospective, observational study using a convenience sample. Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED will also be included in the study. 10. After the invasive intracranial pressure monitoring device is placed, for every recruited patient, ONSD measurements will be taken and the ICP will be recorded 8 hours post placement and then repeated 3 times a day until the intracranial pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision patients, the investigators will obtain a measurement just before surgery, immediately post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to not unnecessarily prolong the hospitalization

Conditions

Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

• The correlation (composite of multiple measurements) of ONSD measurements by sonography in patients with intracranial pressure measurements by invasive intracranial monitors.

  3 years

Secondary Outcomes (1)

• ONSD measurements by sonography in patients with VP shunt malfunction as evidenced by CT scan

  3 years

Study Arms (1)

study subjects

Patients age 0-18 with intracranial monitoring devices in place or requiring a VP shunt revision who receive a ocular ultrasound evaluating ONSD

Procedure: ultrasound

Interventions

ultrasound PROCEDURE

Ocular ultrasound to look at the optic nerve sheath diameter in patients with an intracranial monitoring device or with a ventriculoperitoneal shunt malfunction requiring revision

study subjects

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to PICU and children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED.

You may qualify if:

• Children between 0 years and 18 years of age
• Children who are determined to need an invasive intracranial monitoring device in the ED and admitted to the PICU
• Children who undergo VP shunt revisions at the study site

You may not qualify if:

• Children with an invasive intracranial monitoring device that is malfunctioning
• Prior adverse reactions to ultrasound gel
• Pre-existing ophthalmologic conditions that could cause a baseline increase in ONSD, including glaucoma or severe ocular trauma
• Children with ocular or facial trauma that would impede ONSD measurements

Sponsors & Collaborators

• Anna Rominger: lead

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Anna H Rominger, MD MPH MsC

  University of Louisville

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 18, 2015
• First Posted: July 23, 2015
• Study Start: July 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share