ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 214 for:    Louisville AND placement

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02507063
Recruitment Status : Withdrawn
First Posted : July 23, 2015
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Rominger, University of Louisville

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

Condition or disease Intervention/treatment
Intracranial Hypertension Procedure: ultrasound

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determining the Correlation of Optic Nerve Sheath Diameter With Intracranial Pressure in Children
Study Start Date : July 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. The correlation (composite of multiple measurements) of ONSD measurements by sonography in patients with intracranial pressure measurements by invasive intracranial monitors. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. ONSD measurements by sonography in patients with VP shunt malfunction as evidenced by CT scan [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507063


Sponsors and Collaborators
Anna Rominger
Investigators
Study Director: Anna H Rominger, MD MPH MsC University of Louisville

Responsible Party: Anna Rominger, Assistant Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02507063     History of Changes
Other Study ID Numbers: 15.0326
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases