NCT02283034

Brief Summary

The aim of this study was to compare five 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
120

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
unknown

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
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

October 30, 2014

Last Update Submit

November 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effective compressions was defined as 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 (7)

  • Chest compression depth

    1 month

  • Chest compression rate

    1 month

  • effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]

    1 month

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

    1 month

  • absolute hands-off time was defined as the sum of all periods without chest compressions or ventilation

    1 month

  • +2 more secondary outcomes

Study Arms (2)

With feedback

EXPERIMENTAL

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

Device: Standard BLS

Without feedback

EXPERIMENTAL

Participants compress the chest of the manikin without CPR feedback device

Device: The CPRmeterDevice: The PocketCPRDevice: Standard BLSDevice: The CPREazyDevice: The CPR PRO APPDevice: The CardioPump

Interventions

Feedback device - 1

Without feedback

Feedback device - 2

Without feedback

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

Without feedback

Feedback device - 3

Without feedback

Feedback device - 4

Without feedback

Feedback devices - 5

Without 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 (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

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Andrzej Kurowski

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR
  • Lukasz Szarpak

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
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 5, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations