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Neuroprognostication Using Optic Nerve Sheath Diameter (PANDORA)

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ClinicalTrials.gov Identifier: NCT03195881
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
TriHealth Hatton Research Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Heart Arrest Intracranial Pressure Increase Other: Ocular ultrasound

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.

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Cardiac Arrest Neuroprognostication Using the Diameter of Optic Nerve Sheath Via Ocular ultRAsound
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest


Intervention Details:
  • Other: Ocular 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female post-cardiopulmonary arrest patients ≥ 18 years of age
Criteria

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

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): NCT03195881


Contacts
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Contact: Jocelyn LaMar, BS 513-865-5072 Jocelyn_LaMar@trihealth.com

Locations
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United States, Ohio
Bethesda North TriHealth Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Jocelyn LaMar, BS    513-865-5072    Jocelyn_LaMar@trihealth.com   
Sponsors and Collaborators
TriHealth Inc.
TriHealth Hatton Research Institute
Investigators
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Study Director: Lori Reid, MSN RN CCRC TriHealth Hatton Research Institute

Publications:
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03195881     History of Changes
Other Study ID Numbers: 16-057
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Hypertension
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases