NCT03195881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

October 19, 2020

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

June 2, 2017

Last Update Submit

October 14, 2020

Conditions

Heart ArrestIntracranial Pressure Increase

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter

    Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation

    0-6 hours after hypothermic protocol initiation

Secondary Outcomes (2)

  • Optic nerve sheath diameter

    10-24 hours after hypothermic protocol initiation

  • Optic nerve sheath diameter

    24-36 hours after hypothermic protocol initiation

Other Outcomes (6)

  • Modified Rankin Scale

    Through day 2

  • Modified Rankin Scale

    Through 6 weeks

  • Modified Rankin Scale

    Up to 26 weeks

  • +3 more other outcomes

Interventions

Ocular ultrasoundOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patient \< 18 years of age
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethesda North TriHealth Hospital

Cincinnati, Ohio, 45242, United States

Location

Related Publications (5)

  • 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.

    PMID: 21463263BACKGROUND

  • 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.

    PMID: 20695005BACKGROUND

  • 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.

    PMID: 21524837BACKGROUND

  • 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.

    PMID: 24417885BACKGROUND

  • 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.

    PMID: 28169341BACKGROUND

MeSH Terms

Conditions

Heart ArrestIntracranial Hypertension

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Lori Reid, MSN RN CCRC

    TriHealth Hatton Research Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 22, 2017

Study Start

May 2, 2017

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

October 19, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)