Neuroprognostication Using Optic Nerve Sheath Diameter

Completed

• Conditions: Intracranial Pressure Increase; Heart Arrest

• Registration Number: NCT03195881
• Lead Sponsor: TriHealth Inc.

Brief Summary

This study investigates the relationship between optic nerve sheath diameter and increased intracranial pressure and its effect on neurologic outcome in post-cardiopulmonary arrest patients.

Detailed Description

This study involves patients who have experienced either an in-hospital or out-of-hospital cardiopulmonary arrest, and who meet the 2015 American Heart Association (AHA) inclusion/exclusion criteria for targeted temperature management \[i.e., they are comatose or exhibit no meaningful response to verbal commands with return of spontaneous circulation (ROSC) after cardiac arrest\]. After induction of hypothermia protocol after cardiopulmonary arrest (i.e., targeted temperature management), patients will undergo ocular ultrasound at three time points.

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Status Verified: 2019-08
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patient ≥ 18 years of age
• Patient has experienced either an in-hospital or out-of-hospital cardiopulmonary arrest
• Patient is comatose or exhibits lack of meaningful response to verbal commands with return of spontaneous circulation (ROSC) after cardiopulmonary arrest
• Patient must meet all inclusion criteria as deemed by physician and the 2015 American Heart Association standards for targeted temperature management (TTM) following cardiopulmonary arrest

Exclusion Criteria

• Patient < 18 years of age
• Patient does not meet inclusion criteria for targeted temperature management (TTM)
• Unable to obtain consent from Legal Authorized Representative (LAR)
• Patient has a Do Not Resuscitate (DNR) order or a Do Not Intubate (DNI) order at the time of consent
• Patient has uncontrollable bleeding
• Patient is able to follow verbal commands
• Patient has another medical condition creating increased ocular pressure, as deemed by physician

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter	0-6 hours after hypothermic protocol initiation	Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation

Secondary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter	24-36 hours after hypothermic protocol initiation	Optic nerve sheath diameter 24-36 hours after hypothermic protocol initiation

Trial Locations

Locations (1)

Bethesda North TriHealth Hospital; 🇺🇸 Cincinnati, Ohio, United States