ClinicalTrials.gg
CompletedNCT03771911QRCPUpdated Sep 30, 2019

Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance

An interventional study of AED and Telephone in Cardiopulmonary Resuscitation, sponsored by Bionorte. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Bionorte · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

A simulation study will beperformed. 42 volunteers selected by non-probabilistic sampling will be randomized in two scenarios of cardiac arrest on mannequin: (A) AED-guided CPR and (T) dispatcher-assisted CPR. Simulations last 9 minutes. The quality of CPR will be evaluated by metric monitoring of the chest compressions and timing of actions. A peer's content analysis of the telephone instructions will be performed using a checklist.

02

Conditions studied

  • Cardiopulmonary Resuscitation
03

In context

Lead sponsor

Bionorte is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • untrained laypeople
  • Volunteers

Exclusion criteria

Exclusion Criteria:

  • Pregnants, leg/arm injuried people, chronic back pain.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Other
    AED guided

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

    Device: AED

  • Other
    Telephone guided

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

    Device: AED · Device: Telephone

Interventions

  • DeviceAED

    Instructions provided by an AED

  • DeviceTelephone

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

06

What researchers measure

Primary outcomes

  1. Cardiopulmonary resuscitations strated

    nº of CPR strated by bystander

    Time frame: 9 minutes

Secondary outcomes

  1. Chest compressions rate

    Chest compression/minute

    Time frame: 9 minutes

  2. Chest compressions depth/recoil

    % os chest compressions with correct depth/recoil

    Time frame: 9 minutes

  3. Time under CPR

    % of time applying chest compressions

    Time frame: 8 minutes

  4. Hands on chest

    % of chest compressions with a correct position of hands

    Time frame: 9 minutes

07

Study locations

1 site
  • Hospital de Basurto
    Bilbao, Bizkaia, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03771911
Lead sponsor
Bionorte
Collaborators
University of the Basque Country (UPV/EHU), Osakidetza
Responsible party
Sponsor
First posted
Dec 11, 2018
Start date
Dec 14, 2018
Primary completion
Apr 19, 2019
Completion
May 27, 2019
Last update
Sep 30, 2019

Study contacts

Irrintzi Fernández-Aedo, PhD
study chair · University of the Basque Country (UPV/EHU)
Gorka Vallejo-De la Hoz, PhD
study chair · Osakidetza
Alejandro Etayo-Sancho, RN
study chair · Ambuiberica
Asier Alonso-Pinillos, RN
study chair · Osakidetza
Sendoa Ballesteros-Peña, PhD
study director · Osakidetza

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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