- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195881
Neuroprognostication Using Optic Nerve Sheath Diameter (PANDORA)
October 14, 2020 updated by: TriHealth Inc.
Post Cardiac Arrest Neuroprognostication Using the Diameter of Optic Nerve Sheath Via Ocular ultRAsound
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Bethesda North TriHealth Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male and female post-cardiopulmonary arrest patients ≥ 18 years of age
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optic nerve sheath diameter
Time Frame: 0-6 hours after hypothermic protocol initiation
|
Optic nerve sheath diameter within 6 hours of hypothermic protocol initiation
|
0-6 hours after hypothermic protocol initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optic nerve sheath diameter
Time Frame: 10-24 hours after hypothermic protocol initiation
|
Optic nerve sheath diameter 10-24 hours after hypothermic protocol initiation
|
10-24 hours after hypothermic protocol initiation
|
Optic nerve sheath diameter
Time Frame: 24-36 hours after hypothermic protocol initiation
|
Optic nerve sheath diameter 24-36 hours after hypothermic protocol initiation
|
24-36 hours after hypothermic protocol initiation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Rankin Scale
Time Frame: Through day 2
|
Measure of degree of disability or dependence in daily activities on day of informed consent
|
Through day 2
|
Modified Rankin Scale
Time Frame: Through 6 weeks
|
Measure of degree of disability or dependence in daily activities on day of discharge from ICU'
|
Through 6 weeks
|
Modified Rankin Scale
Time Frame: Up to 26 weeks
|
Measure of degree of disability or dependence in daily activities six months after discharge from ICU
|
Up to 26 weeks
|
Cerebral Performance Category
Time Frame: Through day 2
|
Measure of neurologic outcome following cardiac arrest on day of informed consent
|
Through day 2
|
Cerebral Performance Category
Time Frame: Through 6 weeks
|
Measure of neurologic outcome following cardiac arrest on day of discharge from ICU
|
Through 6 weeks
|
Cerebral Performance Category
Time Frame: Up to 26 weeks
|
Measure of neurologic outcome following cardiac arrest six months after discharge from ICU
|
Up to 26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lori Reid, MSN RN CCRC, TriHealth Hatton Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 2, 2017
Primary Completion (ACTUAL)
December 9, 2019
Study Completion (ACTUAL)
December 9, 2019
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 21, 2017
First Posted (ACTUAL)
June 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2020
Last Update Submitted That Met QC Criteria
October 14, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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