NCT02281903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

October 30, 2014

Last Update Submit

November 15, 2014

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • effective compressions ratio effective compressions [%] multiplied by flow time [%]

    1 month

  • Flow time sum of all periods during which chest compressions were performed.

    1 month

  • absolute hands-off time sum of all periods without chest compressions or ventilation

    1 month

  • Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer

    1 month

Study Arms (1)

Chest compression of manikins chest

EXPERIMENTAL

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

Device: The TrueCPR feedback deviceDevice: Standard BLS

Interventions

The TrueCPR feedback deviceDEVICE

feedback devices

Chest compression of manikins chest
Standard BLSDEVICE

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

Chest compression of manikins chest

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not meet the above criteria
  • wrist or low back diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lukasz Szarpak

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 4, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

PL(1)