NCT02294721

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

November 16, 2014

Last Update Submit

November 16, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effective compressions

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

    1 day

Secondary Outcomes (7)

  • Chest compression depth

    1 day

  • Chest compression rate

    1 day

  • effective compressions ratio

    1day

  • Flow time was defined as the sum of all periods during which chest compressions were performed

    1 day

  • absolute hands-off time

    1 day

  • +2 more secondary outcomes

Study Arms (2)

Without feedback

EXPERIMENTAL

Participants compress the chest of the manikin without CPR feedback device

Device: Standard BLS

With feedback

EXPERIMENTAL

Participants compress the chest of the manikin with CPR feedback device.

Device: The CPREazyDevice: TrueCPRDevice: The CPR PRO APPDevice: The CardioPump

Interventions

Resuscitation without feedback devices, standard manual standard basic life support

Without feedback

feedback device-1

With feedback
TrueCPRDEVICE

feedback device -2

With feedback

feedback device -3

With feedback

feedback device- 4

With feedback

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 (nurses)

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

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lukasz Szarpak

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

November 16, 2014

First Posted

November 19, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations