Neuroprognostication Using Optic Nerve Sheath Diameter

NCT ID: NCT03195881

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-02

Study Completion Date

2019-12-09

Brief Summary

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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

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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.

Conditions

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Heart Arrest Intracranial Pressure Increase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Exclusion Criteria

* Patient \< 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Hatton Research Institute

OTHER

Sponsor Role collaborator

Jocelyn LaMar

UNKNOWN

Sponsor Role collaborator

Emily Craver

UNKNOWN

Sponsor Role collaborator

TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lori Reid, MSN RN CCRC

Role: STUDY_DIRECTOR

TriHealth Hatton Research Institute

Locations

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Bethesda North TriHealth Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Moretti R, Pizzi B. Ultrasonography of the optic nerve in neurocritically ill patients. Acta Anaesthesiol Scand. 2011 Jul;55(6):644-52. doi: 10.1111/j.1399-6576.2011.02432.x. Epub 2011 Apr 4.

Reference Type BACKGROUND
PMID: 21463263 (View on PubMed)

Perkes I, Baguley IJ, Nott MT, Menon DK. A review of paroxysmal sympathetic hyperactivity after acquired brain injury. Ann Neurol. 2010 Aug;68(2):126-35. doi: 10.1002/ana.22066.

Reference Type BACKGROUND
PMID: 20695005 (View on PubMed)

Rittenberger JC, Raina K, Holm MB, Kim YJ, Callaway CW. Association between Cerebral Performance Category, Modified Rankin Scale, and discharge disposition after cardiac arrest. Resuscitation. 2011 Aug;82(8):1036-40. doi: 10.1016/j.resuscitation.2011.03.034. Epub 2011 Apr 13.

Reference Type BACKGROUND
PMID: 21524837 (View on PubMed)

Taccone F, Cronberg T, Friberg H, Greer D, Horn J, Oddo M, Scolletta S, Vincent JL. How to assess prognosis after cardiac arrest and therapeutic hypothermia. Crit Care. 2014 Jan 14;18(1):202. doi: 10.1186/cc13696.

Reference Type BACKGROUND
PMID: 24417885 (View on PubMed)

Wang LJ, Yao Y, Feng LS, Wang YZ, Zheng NN, Feng JC, Xing YQ. Noninvasive and quantitative intracranial pressure estimation using ultrasonographic measurement of optic nerve sheath diameter. Sci Rep. 2017 Feb 7;7:42063. doi: 10.1038/srep42063.

Reference Type BACKGROUND
PMID: 28169341 (View on PubMed)

Other Identifiers

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16-057

Identifier Type: -

Identifier Source: org_study_id

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