NCT03771911

Brief Summary

The aim of this research is to evaluate and to compare the quality of cardiopulmonary resuscitation (CPR) among untrained laypeople under two different scenarios: automated external defibrillator (AED) guided CPR or dispatcher-assisted CPR. Secondarily, to evaluate the quality of the dispatcher-assisted instructions provided from the emergency call center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

First Submitted

Initial submission to the registry

December 2, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

December 14, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
Last Updated

September 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

December 2, 2018

Last Update Submit

September 26, 2019

Conditions

Cardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary resuscitations strated

    nº of CPR strated by bystander

    9 minutes

Secondary Outcomes (4)

  • Chest compressions rate

    9 minutes

  • Chest compressions depth/recoil

    9 minutes

  • Time under CPR

    8 minutes

  • Hands on chest

    9 minutes

Study Arms (2)

AED guided

OTHER

Laypeople will be guided by an Automatic External Defibrillator's (AED) voice instructions during the cardiopulmonary resuscitation. No other help is available.

Device: AED

Telephone guided

OTHER

Laypeople will be guided by telephone assistance (from an Emergency Call Center) during the cardiopulmonary resuscitation. AED voice instructions are also available.

Device: AEDDevice: Telephone

Interventions

AEDDEVICE

Instructions provided by an AED

AED guidedTelephone guided
TelephoneDEVICE

Instructions provided by emergency Call Center (telephonically) with the help of an AED.

Telephone guided

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • untrained laypeople
  • Volunteers

You may not qualify if:

  • Pregnants, leg/arm injuried people, chronic back pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Basurto

Bilbao, Bizkaia, Spain

Location

Study Officials

  • Irrintzi Fernández-Aedo, PhD

    University of the Basque Country (UPV/EHU)

    STUDY CHAIR

  • Gorka Vallejo-De la Hoz, PhD

    Osakidetza

    STUDY CHAIR

  • Alejandro Etayo-Sancho, RN

    Ambuiberica

    STUDY CHAIR

  • Asier Alonso-Pinillos, RN

    Osakidetza

    STUDY CHAIR

  • Sendoa Ballesteros-Peña, PhD

    Osakidetza

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2018

First Posted

December 11, 2018

Study Start

December 14, 2018

Primary Completion

April 19, 2019

Study Completion

May 27, 2019

Last Updated

September 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)