Cardiac ArrestTFSRCASWNCT02866188
The Feasibility Study of Recognition of Cardiac Arrest Using a Smart Watch
An observational study of Cardiac Arrest, run by Hanyang University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Check pulse with Smart watch on 3 parts of patient's body surface
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Shock or Cardiac arrest patients in emergency room.
Who may be able to join
- Over 18 years old
- Shock
- Cardiac arrest
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701
About this study
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.
Read the detailed 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.
- Conditions
- Cardiac Arrest
- Being tested
- Check pulse with Smart watch on 3 parts of patient's body surface
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Check pulse with Smart watch on 3 parts of patient's body surfaceDevice
Check pulse with smart watch on wrist, carotid artery, and eye of patients in shock or cardiac arrest state.
What is being measured
The primary outcome is the main question the study is designed to answer.
The minimum blood pressure on wrist
mmHg, Blood pressure in minimum checkable pulse using smart watch
Measured: 10 seconds
The minimum blood pressure on carotid artery
mmHg, Blood pressure in minimum checkable pulse using smart watch
Measured: 10 seconds
The minimum blood pressure on eye
mmHg, Blood pressure in minimum checkable pulse using smart watch
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YOON-JE, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866188
- Sponsor's protocol ID
- SWROCA
- Acronym
- TFSRCASW
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Study of Recognition of Cardiac Arrest Using a Smart Watch
- ClinicalTrials.gov ID
- NCT02866188
- Acronym / sponsor ID
- TFSRCASW / SWROCA
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Shock or Cardiac arrest patients in emergency room.
Key inclusion criteria (3 listed)
- Over 18 years old
- Shock
- Cardiac arrest
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Check pulse with Smart watch on 3 parts of patient's body surfaceCheck pulse with smart watch on wrist, carotid artery, and eye of patients in shock or cardiac arrest state. | Device | – |
Primary outcome
The minimum blood pressure on wrist
Time frame: 10 seconds
mmHg, Blood pressure in minimum checkable pulse using smart watch
The minimum blood pressure on carotid artery
Time frame: 10 seconds
mmHg, Blood pressure in minimum checkable pulse using smart watch
The minimum blood pressure on eye
Time frame: 10 seconds
mmHg, Blood pressure in minimum checkable pulse using smart watch
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The minimum blood pressure on wrist (time frame: 10 seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.