Clinical trial NCT03195881: Neuroprognostication Using Optic Nerve Sheath Diameter
Official title: Post Cardiac Arrest Neuroprognostication Using the Diameter of Optic Nerve Sheath Via Ocular ultRAsound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest
Intracranial Pressure Increase
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
Collaborators: name: TriHealth Hatton Research Institute
name: Jocelyn LaMar
name: Emily Craver
First posted: 2017-06-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female post-cardiopulmonary arrest patients ≥ 18 years of age

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.

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

Primary outcomes:
measure: Optic nerve sheath diameter
timeFrame: 0-6 hours after hypothermic protocol initiation
Secondary outcomes:
measure: Optic nerve sheath diameter
timeFrame: 10-24 hours after hypothermic protocol initiation
measure: Optic nerve sheath diameter
timeFrame: 24-36 hours after hypothermic protocol initiation
Other outcomes:
measure: Modified Rankin Scale
timeFrame: Through day 2
measure: Modified Rankin Scale
timeFrame: Through 6 weeks
measure: Modified Rankin Scale
timeFrame: Up to 26 weeks
measure: Cerebral Performance Category
timeFrame: Through day 2
measure: Cerebral Performance Category
timeFrame: Through 6 weeks
measure: Cerebral Performance Category
timeFrame: Up to 26 weeks
Locations:
city: Cincinnati
country: United States
facility: Bethesda North TriHealth Hospital
state: Ohio
Study officials:
affiliation: TriHealth Hatton Research Institute
name: Lori Reid, MSN RN CCRC
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.