Neuroprognostication Using Optic Nerve Sheath Diameter (PANDORA)

October 14, 2020 updated by: TriHealth Inc.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North TriHealth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female post-cardiopulmonary arrest patients ≥ 18 years of age

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve sheath diameter
Time Frame: 10-24 hours after hypothermic protocol initiation
Optic nerve sheath diameter 10-24 hours after hypothermic protocol initiation
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
24-36 hours after hypothermic protocol initiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale
Time Frame: Through day 2
Measure of degree of disability or dependence in daily activities on day of informed consent
Through day 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'
Through 6 weeks
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
Up to 26 weeks
Cerebral Performance Category
Time Frame: Through day 2
Measure of neurologic outcome following cardiac arrest on day of informed consent
Through day 2
Cerebral Performance Category
Time Frame: Through 6 weeks
Measure of neurologic outcome following cardiac arrest on day of discharge from ICU
Through 6 weeks
Cerebral Performance Category
Time Frame: Up to 26 weeks
Measure of neurologic outcome following cardiac arrest six months after discharge from ICU
Up to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Lori Reid, MSN RN CCRC, TriHealth Hatton Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2017

Primary Completion (ACTUAL)

December 9, 2019

Study Completion (ACTUAL)

December 9, 2019

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (ACTUAL)

June 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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