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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02646046
Other study ID # CallplusCPR
Secondary ID
Status Completed
Phase N/A
First received December 23, 2015
Last updated September 7, 2016
Start date October 2015
Est. completion date January 2016

Study information

Verified date September 2016
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- All healthy volunteers who attended the basic CPR training class

- Agreement with the simulation trial

Exclusion Criteria:

- volunteers who had some healthy problem which may affect the study results

- Not agreement with the simulation trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Combi lone-CPR
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-CPR
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

Locations

Country Name City State
Korea, Republic of Department of Emergency Medicine, Konkuk University Medical center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Konkuk University Medical Center Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Berg 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. Review. Erratum in: Circulation. 2011 Oct 11;124(15):e402. — View Citation

Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castrén 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. — View Citation

Riera SQ, González BS, Alvarez JT, Fernández Mdel M, Saura JM. The physiological effect on rescuers of doing 2min of uninterrupted chest compressions. Resuscitation. 2007 Jul;74(1):108-12. Epub 2007 Feb 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total numbers of chest compression with correct depth correct depth is defined as depth > 50 mm 3 minutes Yes
Secondary Incomplete release of chest compression 3 minutes Yes
Secondary Incorrect position of chest compression 3 minutes Yes
Secondary Correct Tidal volume defined as 500-800 ml in manikin setting 3 minute Yes
Secondary Interruption time of chest compression 3 minutes Yes
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