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

Sponsor
Bionorte (Other)
Overall Status
Completed
CT.gov ID
NCT03771911
Collaborator
University of the Basque Country (UPV/EHU) (Other), Osakidetza (Other)
42
Enrollment
1
Location
2
Arms
5.4
Actual Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AED
  • Device: Telephone
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance
Actual Study Start Date :
Dec 14, 2018
Actual Primary Completion Date :
Apr 19, 2019
Actual Study Completion Date :
May 27, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cardiopulmonary resuscitations strated [9 minutes]

    nº of CPR strated by bystander

Secondary Outcome Measures

  1. Chest compressions rate [9 minutes]

    Chest compression/minute

  2. Chest compressions depth/recoil [9 minutes]

    % os chest compressions with correct depth/recoil

  3. Time under CPR [8 minutes]

    % of time applying chest compressions

  4. Hands on chest [9 minutes]

    % of chest compressions with a correct position of hands

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • untrained laypeople

  • Volunteers

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Basurto Bilbao Bizkaia Spain

Sponsors and Collaborators

  • Bionorte
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bionorte
ClinicalTrials.gov Identifier:
NCT03771911
Other Study ID Numbers:
  • QRCP
First Posted:
Dec 11, 2018
Last Update Posted:
Sep 30, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 30, 2019