Neuroprognostication Using Optic Nerve Sheath Diameter

Heart Arrest Clinical Trial

— PANDORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195881
• Other study ID #: 16-057
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: December 9, 2019

Study information

• Verified date: August 2019
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Intracranial Hypertension
• 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.

Locations

Country	Name	City	State
United States	Bethesda North TriHealth Hospital	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
TriHealth Inc.	Emily Craver, Jocelyn LaMar, TriHealth Hatton Research Institute

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Rankin Scale	Measure of degree of disability or dependence in daily activities on day of informed consent	Through day 2
Other	Modified Rankin Scale	Measure of degree of disability or dependence in daily activities on day of discharge from ICU'	Through 6 weeks
Other	Modified Rankin Scale	Measure of degree of disability or dependence in daily activities six months after discharge from ICU	Up to 26 weeks
Other	Cerebral Performance Category	Measure of neurologic outcome following cardiac arrest on day of informed consent	Through day 2
Other	Cerebral Performance Category	Measure of neurologic outcome following cardiac arrest on day of discharge from ICU	Through 6 weeks
Other	Cerebral Performance Category	Measure of neurologic outcome following cardiac arrest six months after discharge from ICU	Up to 26 weeks
Primary	Optic nerve sheath diameter	Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation	0-6 hours after hypothermic protocol initiation
Secondary	Optic nerve sheath diameter	Optic nerve sheath diameter 10-24 hours after hypothermic protocol initiation	10-24 hours after hypothermic protocol initiation
Secondary	Optic nerve sheath diameter	Optic nerve sheath diameter 24-36 hours after hypothermic protocol initiation	24-36 hours after hypothermic protocol initiation