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Neurological pupil index and neuron-specific enolase for prediction of outcomes after out-of-hospital cardiac arrest

Status Approved

First Submitted Date

2019/08/21
Registered Date

2019/08/21
Last Updated Date

2019/08/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004229
Unique Protocol ID	B-1905/538-305
Public/Brief Title	Neurological pupil index and neuron-specific enolase for prediction of outcomes after out-of-hospital cardiac arrest
Scientific Title	Neurological pupil index and neuron-specific enolase for prediction of outcomes after out-of-hospital cardiac arrest
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-1905/538-305
Approval Date	2019-05-27
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Dong Keon Lee
Title	D.K Lee
Telephone	+82-31-787-3036
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Contact Person for Public Queries
Name	Haechul Yang
Title	H.C Yang
Telephone	+82-2-787-3031
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Contact Person for Updating Information
Name	Haechul Yang
Title	H.C Yang
Telephone	+82-2-787-3031
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-08-21 Actual
Target Number of Participant	293
Primary Completion Date	2020-12-31 , Anticipated
Study Completion Date	2021-05-26 , Anticipated
Name of Study	Hanyang University Seoul Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-08-21 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute
Project ID	B-1905-538-305

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	purpose of the research -Use the Neurosurgical Motion Index (NPi) and neuron-specific Nolase (NSE). Background of the study Predicting the patient's prognosis is important for the efficient use of limited medical resources and for planning and directing the patient's treatment. Not There is no single way to accurately measure the prognosis of cardiac arrest patients. An integrated approach is essential. Hypothesis of research Prognosis of cardiac arrest patients can be predicted using pupillometry and NSE.

Study Summary Information

Lay Summary

purpose of the research
-Use the Neurosurgical Motion Index (NPi) and neuron-specific Nolase (NSE).

Background of the study
Predicting the patient&#39;s prognosis is important for the efficient use of limited medical resources and for planning and directing the patient&#39;s treatment. Not There is no single way to accurately measure the prognosis of cardiac arrest patients.
An integrated approach is essential.

Hypothesis of research
Prognosis of cardiac arrest patients can be predicted using pupillometry and NSE.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Diagnosis
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Medical Device
Intervention Description	-Instrument for measuring pupillary response to light stimuli -Scan patient's information-> Photostimulation for several seconds according to instructions or protocol and pupil measurement using infrared camera-> Upload patient data to chart -From the patient confirmation to the data input, the machine can objectively evaluate the pupillary response regardless of the examiner and can accurately measure changes up to 0.05mm. Reduces human error in patient identification and records. -Pupil size, percentage constriction, latency, constriction velocity, dilation velocity, etc. are measured and all these values are substituted into the integrated algorithm to obtain NPi scores between 0 and 5.
Number of Arms	1
Arm 1	Arm Label NeurOptics® NPi-200 pupillometer
	Target Number of Participant 293
	Arm Type Experimental
	Arm Description -If cardiopulmonary resuscitation is performed using the 'NeurOptics® NPi-200 pupillometer' machine for the cardiac arrest patients who visited the emergency room, the pupillary response is measured every day for three days after the spontaneous circulation recovery.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I46.9)Cardiac arrest, unspecified Out-of-Hospital Cardiac Arrest
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description Out-of-hospital cardiac arrest patients 18 years and older
Exclusion Criteria	Terminal illness traumatic patient CPC 3-5 before cardiac arrest
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Pupil size
Timepoint	During cardiopulmonary resuscitation, immediately after spontaneous circulation recovery, every 12 hours after spontaneous circulation recovery (up to 72 hours)
Primary Outcome(s) 2
Outcome	reaction rate
Timepoint	During cardiopulmonary resuscitation, immediately after spontaneous circulation recovery, every 12 hours after spontaneous circulation recovery (up to 72 hours)
Primary Outcome(s) 3
Outcome	velocity
Timepoint	During cardiopulmonary resuscitation, immediately after spontaneous circulation recovery, every 12 hours after spontaneous circulation recovery (up to 72 hours)
Primary Outcome(s) 4
Outcome	velocity velocity
Timepoint	During cardiopulmonary resuscitation, immediately after spontaneous circulation recovery, every 12 hours after spontaneous circulation recovery (up to 72 hours)
Primary Outcome(s) 5
Outcome	maximum contraction velocity
Timepoint	During cardiopulmonary resuscitation, immediately after spontaneous circulation recovery, every 12 hours after spontaneous circulation recovery (up to 72 hours)
Secondary Outcome(s) 1
Outcome	neuron-specific enolase
Timepoint	Immediately after spontaneous circulation recovery, every 12 hours after spontaneous circulation recovery (up to 72 hours)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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