Pediatric Resuscitation With Feedback Devices

Cardiac Arrest Clinical Trial

— CPR_NURSE  

Official title:

Quality of Pediatric Chest Compression: Comparing Four CPR Feedback Devices With Standard BLS by a Single Rescuer: A Randomised Controlled Manikin Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02294721
• Other study ID #: CPR/2014/10
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2014
• Last updated: November 16, 2014
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: International Institute of Rescue Research and Education
• Contact: Andrzej Kurowski
• Phone: +48500186225
• Email: andrzejkurowski987[@]gmail.com
• 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 four different CPR feedback devices to standard BLS in terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators hypothesis was that there would be no difference between 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: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 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 (nurses)

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:
• Standard BLS
Resuscitation without feedback devices, standard manual standard basic life support
• The CPREazy
feedback device-1
• TrueCPR
feedback device -2
• The CPR PRO APP
feedback device -3
• The CardioPump
feedback device- 4

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	Effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions	1 day	No
Secondary	Chest compression depth	To measure chest compression depth during 8 minutes. Chest compression depth will be measured using the software connected to the manikin and computer	1 day	No
Secondary	Chest compression rate	To measure the chest compression rate during 8 minutes. Chest compression rate will be measured using the software connected to the manikin and computer	1 day	No
Secondary	effective compressions ratio	effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]	1day	No
Secondary	Flow time was defined as the 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 day	No
Secondary	absolute hands-off time	absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation	1 day	No
Secondary	VAS (visual analogue scale)	after having completed the 8 min testing period, the study participants were asked how challenging they had experienced standard BLS or resuscitation which the respective feedback device. answers were rated on a 10-point Lickert scale (most difficult = 1 to easiest = 10)	1 day	No
Secondary	Prefered CPR device	after having completed the 8 min testing period, the study participants were asked how chellenging whitch method they would preferred. answers were rated on a 10-point Lickert scale (lower preferred = 1 to most preferred = 10)	1 day	No