Out-Of-Hospital Cardiac ArrestNCT05659108
iGOGO -Assessment of CPR Skill,Willingness and Public AED in Layperson:A Cohort Study
An observational study of Out-Of-Hospital Cardiac Arrest, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Out-of-hospital cardiac arrest (OHCA) is an important public health issue. Chang Gung Memorial Hospital, a university affiliated medical center in Taoyuan city, northern Taiwan, actively cooperated with government policy with 250 automated external defibrillators (AED) donation and implementation around many public… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- CPR
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2022to 30 Sep 2023
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Recipient of IGOGO AED donation project, other non-profit group and educational institutions, as well as personnel who participated in the initial and recurrent training in the Formosa Plastics Group including Nanya, Formosa Plastics and Chang Gung.
Who may be able to join
- agree to participate in the CPR course and sign the consent form to take part in the trial for further follow-up.
- satisfies the following age restrictions: a. Legal adult (>20 years old) or b. Underaged (12-20 years old) participants require consent form from the legal guardian.
Who cannot join
- Not willing to participate in the trial signed the consent form
- Inability to perform CPR in a kneeling position
- unwilling to be tracked
- Pregnant
- Hands unable to perform CPR
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Cheng-Yu Chien, 886-987-617998, rainccy217@gmail.com
About this study
Out-of-hospital cardiac arrest (OHCA) is an important public health issue. Chang Gung Memorial Hospital, a university affiliated medical center in Taoyuan city, northern Taiwan, actively cooperated with government policy with 250 automated external defibrillators (AED) donation and implementation around many public places during period of 2012 to 2014. In addition, nearly 200 courses of first aid education and training of citizen were provided in the first and 52 courses in second program. According to the literature, a successful public AED implementation plans proceed with the following requirements: continuing education and training to improve and retain skills; maintaining a proper long-term operation of AED equipment;continued data collection of actual cases for analysis, quality control and feedback. In order to maintain the ability of emergency medical response among these 200 and more AED recipient areas, quality assurance with regular follow-up by medical directors, providing professional advice and feedback, repeat education and training should be proceed.
Read the detailed description
The aim of study is to continue the research development of the previous projects. First, in the previous research projects, investigators were found that the depth and rate of compression will fall behind the current standards by the American Heart Association after one year of training. The E-learning learning website has been completed, so the new project will launch parallel study and tracking of online (AIR) and field (BASE) stimulation teaching for a 2-year period. The participants would be stimulated at 6 and 18 months with short term on-line or base teaching program, and both groups received tests at 1 and 2 years. Second, NCOV-19 epidemic, many courses were cancelled and cannot be trained normally. Investigators will use feedback Annie to understand the operation status of remote students in online courses, and compare them with traditional field courses. (A1 VS B2) Third, the use of public AED for the first shock in OHCA patients were less than 10% in Taiwan. If the first shock could be saved the time, the prognosis of OHCA patients with shockable rhythm will be greatly improved. Therefore, implementing the early activation of the AED donated by our institute is much important. In the previous simulation test, it was found that the continuous education can activate the public AED 1 minute faster than the unit without training. Therefore, in the new plan, investigators Combined with the pre-hospital rescue data of the Taoyuan Fire Department, investigators will analyse the location of publicAED with the GIS and survival correlation. Fourth, investigators would apply the simulation teaching situation in the hospital to the pre-hospital: try to operate the simulation situation teaching plan of OHCA patients in various public places, so that the students can get the impression of the situation and maintain the skills.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- CPR
- Keywords
- Public aid education, cardiopulmonary resuscitation, automated external defibrillators
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPRBehavioural
HIGH QUALITY CPR
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | stimuli with traditional CPR education per half-year Receives: Behavioral: CPR | |
| TREATMENT | stimuli with blended CPR education per half-year Receives: Behavioral: CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful high-quality CPR
The students stimulate with the traditional education group or blended education per half-year. We evaluate the percentage of successful high-quality CPR between traditional and blended education groups.
Measured: we intervention and evaluate the outcome per half-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chip-Jin Ng, Dr., Study chair, Chang Gung Memorial HospitalCheng-Yu Chien, Dr., Study director, Chang Gung Memorial HospitalLi-Heng Tasi, Dr., Study director, Chang Gung Memorial HospitalMing-Fang Wang, Dr., Principal investigator, Chang Gung Memorial HospitalWei-Chen Chen, Dr., Principal investigator, Chang Gung Memorial HospitalYun-Ting Ku, Researcher, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659108
- Sponsor's protocol ID
- 202200559B0
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chien CY, Tsai SL, Huang CH, Wang MF, Lin CC, Chen CB, Tsai LH, Tseng HJ, Huang YB, Ng CJ. Effectiveness of Blended Versus Traditional Refresher Training for Cardiopulmonary Resuscitation: Prospective Observational Study. JMIR Med Educ. 2024 Apr 29;10:e52230. doi: 10.2196/52230.
PubMed 38683663
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iGOGO -Assessment of CPR Skill,Willingness and Public AED in Layperson:A Cohort Study
- ClinicalTrials.gov ID
- NCT05659108
- Acronym / sponsor ID
- 202200559B0
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Public aid education, cardiopulmonary resuscitation, automated external defibrillators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- 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.
Out-of-hospital cardiac arrest (OHCA) is an important public health issue. Chang Gung Memorial Hospital, a university affiliated medical center in Taoyuan city, northern Taiwan, actively cooperated with government policy with 250 automated external defibrillators (AED) donation and implementation around many public places during period of 2012 to 2014. In addition, nearly 200 courses of first aid education and training of citizen were provided in the first and 52 courses in second program. According to the literature, a successful public AED implementation plans proceed with the following requirements: continuing education and training to improve and retain skills; maintaining a proper long-term operation of AED equipment;continued data collection of actual cases for analysis, quality control and feedback. In order to maintain the ability of emergency medical response among these 200 and more AED recipient areas, quality assurance with regular follow-up by medical directors, providing professional advice and feedback, repeat education and training should be proceed.
Detailed description
The aim of study is to continue the research development of the previous projects. First, in the previous research projects, investigators were found that the depth and rate of compression will fall behind the current standards by the American Heart Association after one year of training. The E-learning learning website has been completed, so the new project will launch parallel study and tracking of online (AIR) and field (BASE) stimulation teaching for a 2-year period. The participants would be stimulated at 6 and 18 months with short term on-line or base teaching program, and both groups received tests at 1 and 2 years. Second, NCOV-19 epidemic, many courses were cancelled and cannot be trained normally. Investigators will use feedback Annie to understand the operation status of remote students in online courses, and compare them with traditional field courses. (A1 VS B2) Third, the use of public AED for the first shock in OHCA patients were less than 10% in Taiwan. If the first shock could be saved the time, the prognosis of OHCA patients with shockable rhythm will be greatly improved. Therefore, implementing the early activation of the AED donated by our institute is much important. In the previous simulation test, it was found that the continuous education can activate the public AED 1 minute faster than the unit without training. Therefore, in the new plan, investigators Combined with the pre-hospital rescue data of the Taoyuan Fire Department, investigators will analyse the location of publicAED with the GIS and survival correlation. Fourth, investigators would apply the simulation teaching situation in the hospital to the pre-hospital: try to operate the simulation situation teaching plan of OHCA patients in various public places, so that the students can get the impression of the situation and maintain the skills.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | – | Behavioral: CPRstimuli with traditional CPR education per half-year |
| TREATMENT | – | Behavioral: CPRstimuli with blended CPR education per half-year |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Recipient of IGOGO AED donation project, other non-profit group and educational institutions, as well as personnel who participated in the initial and recurrent training in the Formosa Plastics Group including Nanya, Formosa Plastics and Chang Gung.
Key inclusion criteria (2 listed)
- agree to participate in the CPR course and sign the consent form to take part in the trial for further follow-up.
- satisfies the following age restrictions: a. Legal adult (>20 years old) or b. Underaged (12-20 years old) participants require consent form from the legal guardian.
Key exclusion criteria (5 listed)
- Not willing to participate in the trial signed the consent form
- Inability to perform CPR in a kneeling position
- unwilling to be tracked
- Pregnant
- Hands unable to perform CPR
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 |
|---|---|---|
| CPRHIGH QUALITY CPR | Behavioural | CONTROL, TREATMENT |
Primary outcome
Percentage of successful high-quality CPR
Time frame: we intervention and evaluate the outcome per half-year
The students stimulate with the traditional education group or blended education per half-year. We evaluate the percentage of successful high-quality CPR between traditional and blended education groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 38683663Chien CY, Tsai SL, Huang CH, Wang MF, Lin CC, Chen CB, Tsai LH, Tseng HJ, Huang YB, Ng CJ. Effectiveness of Blended Versus Traditional Refresher Training for Cardiopulmonary Resuscitation: Prospective Observational Study. JMIR Med Educ. 2024 Apr 29;10:e52230. doi: 10.2196/52230.
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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.
Chip-Jin Ng, Dr. study chair
Chang Gung Memorial Hospital
Cheng-Yu Chien, Dr. study director
Chang Gung Memorial Hospital
Li-Heng Tasi, Dr. study director
Chang Gung Memorial Hospital
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 Out-Of-Hospital Cardiac Arrest, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 5 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 21 Dec 2022. 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 Taiwan. 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?
Contact Cheng-Yu Chien, Dr. (886-987-617998, rainccy217@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of successful high-quality CPR (time frame: we intervention and evaluate the outcome per half-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659108, which also lists 1 linked publication.
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 21 Dec 2022.