PRFD: Pediatric Resuscitation With Feedback CPR Devices

Sponsor

International Institute of Rescue Research and Education (Other)

Overall Status

Completed

CT.gov ID

NCT02281903

Collaborator

(none)

132

Enrollment

Location

Arm

Duration (Months)

129.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Device: The TrueCPR feedback device Device: Standard BLS	N/A

Detailed Description

Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.

Study Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chest compression of manikins chest Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation.	Device: The TrueCPR feedback device feedback devices Device: Standard BLS Standard basic life support = chest compressions without any feedback device (manual resuscitation)

Arm

Intervention/Treatment

Experimental: Chest compression of manikins chest

Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation.

Device: The TrueCPR feedback device

feedback devices

Device: Standard BLS

Standard basic life support = chest compressions without any feedback device (manual resuscitation)

Outcome Measures

Primary Outcome Measures

Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions [1 month]
effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions

Secondary Outcome Measures

effective compressions ratio effective compressions [%] multiplied by flow time [%] [1 month]
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
Flow time sum of all periods during which chest compressions were performed. [1 month]
flow time was defined as the sum of all periods during which chest compressions were performed.
absolute hands-off time sum of all periods without chest compressions or ventilation [1 month]
absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation
Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer [1 month]
compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

give voluntary consent to participate in the study
medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

not meet the above criteria
wrist or low back diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Institute of Rescue Research and Education	Warsaw	Masovia	Poland	03-122

Sponsors and Collaborators

International Institute of Rescue Research and Education

Investigators

Principal Investigator: Lukasz Szarpak, Institute of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland

ClinicalTrials.gov Identifier:

NCT02281903

Other Study ID Numbers:

CPR/2014/05

First Posted:

Nov 4, 2014

Last Update Posted:

Nov 18, 2014

Last Verified:

Nov 1, 2014

Additional relevant MeSH terms:

Heart Arrest

Study Results

No Results Posted as of Nov 18, 2014