Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance (QRCP)

September 26, 2019 updated by: Bionorte
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Bizkaia
      • Bilbao, Bizkaia, Spain
        • Hospital De Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • untrained laypeople
  • Volunteers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Instructions provided by an 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
Instructions provided by an AED
Device: Telephone
Instructions provided by emergency Call Center (telephonically) with the help of an AED.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary resuscitations strated
Time Frame: 9 minutes
nº of CPR strated by bystander
9 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest compressions rate
Time Frame: 9 minutes
Chest compression/minute
9 minutes
Chest compressions depth/recoil
Time Frame: 9 minutes
% os chest compressions with correct depth/recoil
9 minutes
Time under CPR
Time Frame: 8 minutes
% of time applying chest compressions
8 minutes
Hands on chest
Time Frame: 9 minutes
% of chest compressions with a correct position of hands
9 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bionorte

Collaborators

University of the Basque Country (UPV/EHU)
Osakidetza

Investigators

  • Study Chair: 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 Director: Sendoa Ballesteros-Peña, PhD, Osakidetza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2018

Primary Completion (Actual)

April 19, 2019

Study Completion (Actual)

May 27, 2019

Study Registration Dates

First Submitted

December 2, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • QRCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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