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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.

Tracking Information
First Submitted Date June 2, 2017
First Posted Date June 22, 2017
Last Update Posted Date August 16, 2019
Actual Study Start Date May 2, 2017
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2017)
Optic nerve sheath diameter [ Time Frame: 0-6 hours after hypothermic protocol initiation ]
Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03195881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 21, 2017)
  • Optic nerve sheath diameter [ Time Frame: 10-24 hours after hypothermic protocol initiation ]
    Optic nerve sheath diameter 10-24 hours after hypothermic protocol initiation
  • Optic nerve sheath diameter [ Time Frame: 24-36 hours after hypothermic protocol initiation ]
    Optic nerve sheath diameter 24-36 hours after hypothermic protocol initiation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2017)
  • Modified Rankin Scale [ Time Frame: Through day 2 ]
    Measure of degree of disability or dependence in daily activities on day of informed consent
  • Modified Rankin Scale [ Time Frame: Through 6 weeks ]
    Measure of degree of disability or dependence in daily activities on day of discharge from ICU`
  • 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
  • Cerebral Performance Category [ Time Frame: Through day 2 ]
    Measure of neurologic outcome following cardiac arrest on day of informed consent
  • Cerebral Performance Category [ Time Frame: Through 6 weeks ]
    Measure of neurologic outcome following cardiac arrest on day of discharge from ICU
  • Cerebral Performance Category [ Time Frame: Up to 26 weeks ]
    Measure of neurologic outcome following cardiac arrest six months after discharge from ICU
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Neuroprognostication Using Optic Nerve Sheath Diameter
Official Title Post Cardiac Arrest Neuroprognostication Using the Diameter of Optic Nerve Sheath Via Ocular ultRAsound
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male and female post-cardiopulmonary arrest patients ≥ 18 years of age
Condition
  • Heart Arrest
  • Intracranial Pressure Increase
Intervention 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 21, 2017)
62
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jocelyn LaMar, BS 513-865-5072 Jocelyn_LaMar@trihealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03195881
Other Study ID Numbers 16-057
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party TriHealth Inc.
Study Sponsor TriHealth Inc.
Collaborators TriHealth Hatton Research Institute
Investigators
Study Director: Lori Reid, MSN RN CCRC TriHealth Hatton Research Institute
PRS Account TriHealth Inc.
Verification Date August 2019