PANDORA: Neuroprognostication Using Optic Nerve Sheath Diameter
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Outcome Measures
Primary Outcome Measures
- Optic nerve sheath diameter [0-6 hours after hypothermic protocol initiation]
Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation
Secondary Outcome Measures
- Optic nerve sheath diameter [10-24 hours after hypothermic protocol initiation]
Optic nerve sheath diameter 10-24 hours after hypothermic protocol initiation
- Optic nerve sheath diameter [24-36 hours after hypothermic protocol initiation]
Optic nerve sheath diameter 24-36 hours after hypothermic protocol initiation
Other Outcome Measures
- Modified Rankin Scale [Through day 2]
Measure of degree of disability or dependence in daily activities on day of informed consent
- Modified Rankin Scale [Through 6 weeks]
Measure of degree of disability or dependence in daily activities on day of discharge from ICU'
- Modified Rankin Scale [Up to 26 weeks]
Measure of degree of disability or dependence in daily activities six months after discharge from ICU
- Cerebral Performance Category [Through day 2]
Measure of neurologic outcome following cardiac arrest on day of informed consent
- Cerebral Performance Category [Through 6 weeks]
Measure of neurologic outcome following cardiac arrest on day of discharge from ICU
- Cerebral Performance Category [Up to 26 weeks]
Measure of neurologic outcome following cardiac arrest six months after discharge from ICU
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bethesda North TriHealth Hospital | Cincinnati | Ohio | United States | 45242 |
Sponsors and Collaborators
- TriHealth Inc.
- TriHealth Hatton Research Institute
- Jocelyn LaMar
- Emily Craver
Investigators
- Study Director: Lori Reid, MSN RN CCRC, TriHealth Hatton Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 16-057