Pediatric Resuscitation With Feedback CPR Devices

Cardiac Arrest Clinical Trial

— PRFD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281903
• Other study ID #: CPR/2014/05
• Status: Completed
• Phase: N/A
• First received: October 30, 2014
• Last updated: November 15, 2014
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: International Institute of Rescue Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• The TrueCPR feedback device
feedback devices
• Standard BLS
Standard basic life support = chest compressions without any feedback device (manual resuscitation)

Locations

Country	Name	City	State
Poland	International Institute of Rescue Research and Education	Warsaw	Masovia

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions	effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions	1 month	No
Secondary	effective compressions ratio effective compressions [%] multiplied by flow time [%]	effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]	1 month	No
Secondary	Flow time sum of all periods during which chest compressions were performed.	flow time was defined as the sum of all periods during which chest compressions were performed.	1 month	No
Secondary	absolute hands-off time sum of all periods without chest compressions or ventilation	absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation	1 month	No
Secondary	Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer	compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer	1 month	No