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Completed

NCT Number: NCT03195881

Neuroprognostication Using Optic Nerve Sheath Diameter

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bethesda North TriHealth Hospital

Cincinnati, Ohio, 45242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocular ultrasound

Other

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.

Primary outcomes

  1. Optic nerve sheath diameter

    Time frame: 0-6 hours after hypothermic protocol initiation

    Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation

Secondary outcomes

  1. Optic nerve sheath diameter

    Time frame: 10-24 hours after hypothermic protocol initiation

    Optic nerve sheath diameter 10-24 hours after hypothermic protocol initiation

  2. Optic nerve sheath diameter

    Time frame: 24-36 hours after hypothermic protocol initiation

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

Other outcomes

  1. Modified Rankin Scale

    Time frame: Through day 2

    Measure of degree of disability or dependence in daily activities on day of informed consent

  2. Modified Rankin Scale

    Time frame: Through 6 weeks

    Measure of degree of disability or dependence in daily activities on day of discharge from ICU'

  3. Modified Rankin Scale

    Time frame: Up to 26 weeks

    Measure of degree of disability or dependence in daily activities six months after discharge from ICU

  4. Cerebral Performance Category

    Time frame: Through day 2

    Measure of neurologic outcome following cardiac arrest on day of informed consent

  5. Cerebral Performance Category

    Time frame: Through 6 weeks

    Measure of neurologic outcome following cardiac arrest on day of discharge from ICU

  6. Cerebral Performance Category

    Time frame: Up to 26 weeks

    Measure of neurologic outcome following cardiac arrest six months after discharge from ICU

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Collaborators

  • Emily Craver
  • Jocelyn LaMar
  • TriHealth Hatton Research Institute

Registry information

Official study title

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

Acronym: PANDORA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2017
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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