Neuroprognostication Using Optic Nerve Sheath Diameter

Post Cardiac Arrest Neuroprognostication Using the Diameter of Optic Nerve Sheath Via Ocular ultRAsound

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03195881

Acronym

PANDORA

Enrollment

Registered

2017-06-22

Start date

2017-05-02

Completion date

2019-12-09

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Arrest, Intracranial Pressure Increase

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.

Interventions

OTHEROcular ultrasound

Post-cardiopulmonary arrest patients meeting inclusion/exclusion criteria for targeted temperature management will undergo ocular ultrasound at three time points: within 6 hours (h) of initiation of hypothermic protocol, between 10-24 h after hypothermic protocol initiation, and between 24-36 h after hypothermic protocol initiation.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Optic nerve sheath diameter	0-6 hours after hypothermic protocol initiation	Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation

Secondary

Measure	Time frame	Description
Optic nerve sheath diameter	10-24 hours after hypothermic protocol initiation	Optic nerve sheath diameter 10-24 hours after hypothermic protocol initiation

Other

Measure	Time frame	Description
Modified Rankin Scale	Through day 2	Measure of degree of disability or dependence in daily activities on day of informed consent
Cerebral Performance Category	Through day 2	Measure of neurologic outcome following cardiac arrest on day of informed consent

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026