Out-of-Hospital Cardiac ArrestNCT02646046
Combining Performance of Call EMS and Simultaneous Chest Compressions in a Lone Rescuer CPR
A study testing Combi lone-CPR and Conventional lone-CPR in people with Out-of-Hospital Cardiac Arrest, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Investigators designed the novel combining technique that rescuer start the chest compression with one hand during calling for help to the Emergency Medical System (EMS) via a cell phone with another hand when he witnessed the arrest victim. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- Combi lone-CPR and Conventional lone-CPR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Jan 2016
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All healthy volunteers who attended the basic CPR training class
- Agreement with the simulation trial
Who cannot join
- volunteers who had some healthy problem which may affect the study results
- Not agreement with the simulation trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Emergency Medicine, Konkuk University Medical center
Seoul, 143-729
About this study
Official title: A Study of Evaluation of Effectiveness on the Combining Performance of Call Emergency Medical System (EMS) and Simultaneous Chest Compressions With One Hand in a Lone Rescuer CPR: a Simulation Study Using the Manikin
Investigators designed the novel combining technique that rescuer start the chest compression with one hand during calling for help to the Emergency Medical System (EMS) via a cell phone with another hand when he witnessed the arrest victim. This method may be helpful to reduce the hand-off time and increase the faction time of chest compression until the arrival of EMS members.
To verify this hypothesis, we conducted a random, controlled simulation study.
Read the detailed description
This study used a random, controlled design in the simulation setting using a manikin. Study participants were recruited from healthy adult (age > 18 years) laypersons who attended the BLS training courses provided by the BLS training class.
The simulation scenario consists of witness of an out of hospital cardiac arrest and activation of the EMS system with the prepared cellular phone. Interventional method contained the immediate starting of the chest compression with one hand during the calling for help to the EMS via a cell phone with another hand.
We compare the quality of CPR between the novel interventional method (start CPR during Call to EMS) and conventional method (First Call to EMS and then start CPR).
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- Combi lone-CPR, Conventional lone-CPR
- Keywords
- Cardiopulmonary Resuscitation, Emergency Medical Services, Cell phones, Simulation Training
- 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.
Combi lone-CPRBehavioural
When study participants meet the arrest victim (simulated), they start chest compression and call for help to EMS at the same time, then continue the chest compression and 2 breath alternatively until the EMS arrival
Conventional lone-CPRBehavioural
When study participants meet the arrest victim (simulated), they first call for help to EMS and then start chest compression and 2 breath alternatively until the EMS arrival
| Study group | Role | What they receive |
|---|---|---|
| Combi lone-CPR | Experimental | Intervention group
: Newly developed method Receives: Behavioral: Combi lone-CPR |
| Conventional lone-CPR | Active comparator | Conventional CPR group Receives: Behavioral: Conventional lone-CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total numbers of chest compression with correct depth
correct depth is defined as depth > 50 mm
Measured: 3 minutes
Secondary outcomes (4)
Incomplete release of chest compression
Measured: 3 minutes
Incorrect position of chest compression
Measured: 3 minutes
Correct Tidal volume
defined as 500-800 ml in manikin setting
Measured: 3 minute
Interruption time of chest compression
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Medical Center
- Responsible party
- Principal investigator, Sang O, Park, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646046
- Sponsor's protocol ID
- CallplusCPR
- Status last verified
- Sep 2016
- First submitted
- 23 Dec 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castren M, Granja C, Handley AJ, Monsieurs KG, Perkins GD, Raffay V, Sandroni C. European Resuscitation Council Guidelines for Resuscitation 2010 Section 2. Adult basic life support and use of automated external defibrillators. Resuscitation. 2010 Oct;81(10):1277-92. doi: 10.1016/j.resuscitation.2010.08.009. No abstract available.
PubMed 20956051Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939.
PubMed 20956221Riera SQ, Gonzalez BS, Alvarez JT, Fernandez Mdel M, Saura JM. The physiological effect on rescuers of doing 2min of uninterrupted chest compressions. Resuscitation. 2007 Jul;74(1):108-12. doi: 10.1016/j.resuscitation.2006.10.031. Epub 2007 Feb 14.
PubMed 17303308
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Evaluation of Effectiveness on the Combining Performance of Call Emergency Medical System (EMS) and Simultaneous Chest Compressions With One Hand in a Lone Rescuer CPR: a Simulation Study Using the Manikin
- ClinicalTrials.gov ID
- NCT02646046
- Acronym / sponsor ID
- CallplusCPR
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Cardiopulmonary Resuscitation, Emergency Medical Services, Cell phones, Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Hallym University Medical Center
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Jan 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.
Investigators designed the novel combining technique that rescuer start the chest compression with one hand during calling for help to the Emergency Medical System (EMS) via a cell phone with another hand when he witnessed the arrest victim. This method may be helpful to reduce the hand-off time and increase the faction time of chest compression until the arrival of EMS members.
To verify this hypothesis, we conducted a random, controlled simulation study.
Detailed description
This study used a random, controlled design in the simulation setting using a manikin. Study participants were recruited from healthy adult (age > 18 years) laypersons who attended the BLS training courses provided by the BLS training class.
The simulation scenario consists of witness of an out of hospital cardiac arrest and activation of the EMS system with the prepared cellular phone. Interventional method contained the immediate starting of the chest compression with one hand during the calling for help to the EMS via a cell phone with another hand.
We compare the quality of CPR between the novel interventional method (start CPR during Call to EMS) and conventional method (First Call to EMS and then start CPR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combi lone-CPR | Experimental | Behavioral: Combi lone-CPRIntervention group : Newly developed method |
| Conventional lone-CPR | Active comparator | Behavioral: Conventional lone-CPRConventional CPR group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All healthy volunteers who attended the basic CPR training class
- Agreement with the simulation trial
Key exclusion criteria (2 listed)
- volunteers who had some healthy problem which may affect the study results
- Not agreement with the simulation trial
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 |
|---|---|---|
| Combi lone-CPRWhen study participants meet the arrest victim (simulated), they start chest compression and call for help to EMS at the same time, then continue the chest compression and 2 breath alternatively until the EMS arrival | Behavioural | Combi lone-CPR |
| Conventional lone-CPRWhen study participants meet the arrest victim (simulated), they first call for help to EMS and then start chest compression and 2 breath alternatively until the EMS arrival | Behavioural | Conventional lone-CPR |
Primary outcome
Total numbers of chest compression with correct depth
Time frame: 3 minutes
correct depth is defined as depth > 50 mm
4 secondary outcomes
Incomplete release of chest compression
Time frame: 3 minutes
Incorrect position of chest compression
Time frame: 3 minutes
Correct Tidal volume
Time frame: 3 minute
Interruption time of chest compression
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Background: PubMed 20956051Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castren M, Granja C, Handley AJ, Monsieurs KG, Perkins GD, Raffay V, Sandroni C. European Resuscitation Council Guidelines for Resuscitation 2010 Section 2. Adult basic life support and use of automated external defibrillators. Resuscitation. 2010 Oct;81(10):1277-92. doi: 10.1016/j.resuscitation.2010.08.009. No abstract available.
- Background: PubMed 20956221Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939.
- Background: PubMed 17303308Riera SQ, Gonzalez BS, Alvarez JT, Fernandez Mdel M, Saura JM. The physiological effect on rescuers of doing 2min of uninterrupted chest compressions. Resuscitation. 2007 Jul;74(1):108-12. doi: 10.1016/j.resuscitation.2006.10.031. Epub 2007 Feb 14.
- Individual participant dataSharing planned: No
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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?
A study testing Combi lone-CPR and Conventional lone-CPR in people with Out-of-Hospital Cardiac Arrest, run by Konkuk University Medical Center 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total numbers of chest compression with correct depth (time frame: 3 minutes). 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 NCT02646046, which also lists 3 linked publications.
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 8 Sep 2016.