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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02866188
Other study ID # SWROCA
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 10, 2016
Last updated August 12, 2016
Start date August 2016
Est. completion date December 2016

Study information

Verified date August 2016
Source Hanyang University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

In this study, we want to find out whether the recognition of cardiac arrest using a smart watch is feasible or not. If this idea is possible, the recognition of cardiac arrest using the smart watch is easy and fast to the witness, like a general person. By using the smart watch, the emergency response system for cardiac arrest and the bystander CPR or BLS is beginning earlier than using conventional cardiac arrest recognition method in field.


Description:

In Korea, an out-of-hospital cardiac arrest (OHCA) was occurred twenty thousand person per year, and among them sixty percent was occurred in their home. We already knew that a survivor rate and neurological outcome of OHCA patient has a close relation with initial emergency management in field, like a bystander cardiopulmonary resuscitation (CPR), Basic Life Support (BLS), etc. However, in Korea, a witness almost did not the bystander CPR or BLS in field until highly trained rescuers arrived there. So, total survivor rate is just 2.4 % irrespective of neurologic outcome in Korea.

Generally, in Korea, a beginning of the bystander CPR progress throughout dispatcher's instruction of emergency response system. This system for OHCA patient activate only when the witness recognize cardiac arrest and call the emergency response system. Therefore, cardiac arrest recognition by the witness is very important.

However, a conventional recognition of cardiac arrest in field is often difficult, because there are no monitoring devices, healthcare providers. The conventional recognition method of cardiac arrest is that it is firstly to check mental status, secondly check pulse on patient's carotid artery and self-respiration. This method is too difficult for the witness, especially general persons. Even, it is difficult for an emergency physicians, too.

Consequentially, the recognition of cardiac arrest by the witness is generally delayed, a golden-time is running out until highly trained rescuers arrive there. An average arrival time of highly trained rescuers is eight to ten minutes. A hypoxic brain damage is begin from four minutes after cardiac arrest. As a result, this delayed time is already passed four minutes after cardiac arrest. So, the survivor rate and the neurologic outcome are not good enough.

In this study, we want to find out whether the recognition of cardiac arrest using a smart watch is feasible or not. If this idea is possible, the recognition of cardiac arrest using the smart watch is easy and fast to the witness, like a general person. By using the smart watch, the emergency response system for cardiac arrest and the bystander CPR or BLS is beginning earlier than using conventional cardiac arrest recognition method in field.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Over 18 years old

- Shock

- Cardiac arrest

Exclusion Criteria:

- Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Check pulse with Smart watch on 3 parts of patient's body surface
Check pulse with smart watch on wrist, carotid artery, and eye of patients in shock or cardiac arrest state.

Locations

Country Name City State
Korea, Republic of Hanyang University Guri Hospital Guri-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The minimum blood pressure on wrist mmHg, Blood pressure in minimum checkable pulse using smart watch 10 seconds No
Primary The minimum blood pressure on carotid artery mmHg, Blood pressure in minimum checkable pulse using smart watch 10 seconds No
Primary The minimum blood pressure on eye mmHg, Blood pressure in minimum checkable pulse using smart watch 10 seconds No
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