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Effect of head elevation during cardiopulmonary resuscitation on cerebral blood flow in out-of-hospital cardiac arrest: a pilot study

Status Approved

First Submitted Date

2020/03/31
Registered Date

2020/07/01
Last Updated Date

2020/10/03

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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	KCT0005191
Unique Protocol ID	B-1906-549-001
Public/Brief Title	Effect of head elevation during cardiopulmonary resuscitation on cerebral blood flow during cardiac arrest: a pilot study
Scientific Title	Effect of head elevation during cardiopulmonary resuscitation on cerebral blood flow in out-of-hospital cardiac arrest: a pilot study
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-1906/549-001
Approval Date	2019-09-06
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	Professor
Telephone	+82-31-1588-3369
Affiliation	Seoul National University Bundang Hospital
Address	82, Kumi-ro 173th, Bundang-ku Seongnam, Gyeonggi 13620, Republic of Korea.
Contact Person for Public Queries
Name	Young Taeck Oh
Title	Professor
Telephone	+82-31-1588-3369
Affiliation	Seoul National University Bundang Hospital
Address	82, Kumi-ro 173th, Bundang-ku Seongnam, Gyeonggi 13620, Republic of Korea.
Contact Person for Updating Information
Name	Young Taeck Oh
Title	Professor
Telephone	+82-31-1588-3369
Affiliation	Seoul National University Bundang Hospital
Address	82, Kumi-ro 173th, Bundang-ku Seongnam, Gyeonggi 13620, Republic of Korea.

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	2019-12-25 Actual
Target Number of Participant	30
Primary Completion Date	2020-10-30 , Anticipated
Study Completion Date	2020-12-31 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-12-25 ,

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-1906/549-001

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	1. Background Out-of-hospital cardiac arrest(OHCA) patients have a low survival rate, and few neurologically intact survival. Recently, several animal experiments were introduced related to head-up cardiopulmonary resuscitation(CPR) and they revealed that head-up CPR lowered intracranial pressure and heightened cerebral perfusion. To check cerebral perfusion, the invasive catheter should be inserted and it is impossible in the human who undergoes CPR. near-infrared spectroscopy(NIRS) can check oxy/deoxyhemoglobin in some part of the brain, using NIRS we can calculate cerebral perfusion. 2. Hypothesis and purpose Head-up CPR may improve in cerebral perfusion of OHCA patients. And it may improve neurological outcome. 3. Plan Out-of-hospital cardiac arrest patient undergoes cardiac pulmonary resuscitation(CPR) in a supine position when they present to the emergency room. Using near-infrared spectroscopy, brain perfusion was checked in 4 minutes during CPR. After 4 minutes, the medical practitioner changes patient's position to head up position and resumes CPR. and then, the medical practitioner switches the patient's position in each 4 minutes period.

Study Summary Information

Lay Summary

1. Background
Out-of-hospital cardiac arrest(OHCA) patients have a low survival rate, and few neurologically intact survival. 
Recently, several animal experiments were introduced related to head-up cardiopulmonary resuscitation(CPR) and they revealed that head-up CPR lowered intracranial pressure and heightened cerebral perfusion.
To check cerebral perfusion, the invasive catheter should be inserted and it is impossible in the human who undergoes CPR.
near-infrared spectroscopy(NIRS) can check oxy/deoxyhemoglobin in some part of the brain, using NIRS we can calculate cerebral perfusion.

2. Hypothesis and purpose
Head-up CPR may improve in cerebral perfusion of OHCA patients. And it may improve neurological outcome.

3. Plan
Out-of-hospital cardiac arrest patient undergoes cardiac pulmonary resuscitation(CPR) in a supine position when they present to the emergency room. Using near-infrared spectroscopy, brain perfusion was checked in 4 minutes during CPR. After 4 minutes, the medical practitioner changes patient&#39;s position to head up position and resumes CPR. and then,  the medical practitioner switches the patient&#39;s position in each 4 minutes period.

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	Supportive Care
Phase	Not applicable
Intervention Model	Cross-over
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Others
Intervention Description	Out-of-hospital cardiac arrest patient undergoes cardiac pulmonary resuscitation(CPR) in a supine position when they present to the emergency room. Using near-infrared spectroscopy, brain perfusion was checked in 4 minutes during CPR. After 4 minutes, the medical practitioner changes patient's position to head up position and resumes CPR. and then, the medical practitioner switches the patient's position in each 4 minutes period.
Number of Arms	2
Arm 1	Arm Label Cross-over study
	Target Number of Participant 30
	Arm Type Others
	Arm Description After changing the patient's position supine to head up, brain perfusion was checked in 4 minutes during cardiopulmonary resuscitation using near-infrared spectroscopy.
Arm 2	Arm Label Cross-over study
	Target Number of Participant 30
	Arm Type Others
	Arm Description After changing the patient's position head up to supine, brain perfusion was checked in 4 minutes during cardiopulmonary resuscitation using near-infrared spectroscopy.

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 patient
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~130Year
	Description All out-of-cardiac arrest patients who present the emergency department were included except those who meet exclusion criteria as below.
Exclusion Criteria	Pediatrics(below 18 years old), traumatic arrest, history of brain tumor, ischemic stroke, hemorrhagic stroke underwent surgery
Healthy Volunteers	No

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	Efficacy
Outcome	To check delta oxy- and deoxyhemoglobin values and calculate cerebral perfusion.
Timepoint	To check brain perfusion variables in switching supine position and head-up position in every 4 minutes.
Secondary Outcome(s) 1
Outcome	To check the cerebral performance category of patients using a phone call.
Timepoint	After 6 months

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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