Cardiopulmonary ResuscitationQRCPNCT03771911

Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance

A study testing AED and Telephone in people with Cardiopulmonary Resuscitation, run by Bionorte at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Cardiopulmonary Resuscitation
What is being tested?: AED and Telephone
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteSpain
Study dates: 14 Dec 2018to 27 May 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

untrained laypeople
Volunteers

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital de Basurto
Bilbao, Bizkaia

Other trials in Spain

About this study

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.

Conditions: Cardiopulmonary Resuscitation
Being tested: AED, Telephone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03771911
Study group	Role	What they receive
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. Receives: 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. Receives: Device: AED; Device: Telephone

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiopulmonary resuscitations strated
nº of CPR strated by bystander
Measured: 9 minutes

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 201827 May 2019

First posted11 Dec 2018
Study start14 Dec 2018
Primary completion19 Apr 2019
Study completion27 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03771911
Sponsor's protocol ID: QRCP
Acronym: QRCP
Status last verified: May 2019
First submitted: 2 Dec 2018
Last updated: 30 Sep 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension

All Cardiopulmonary Resuscitation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance
ClinicalTrials.gov ID: NCT03771911
Acronym / sponsor ID: QRCP / QRCP
Conditions: Cardiopulmonary Resuscitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: BionorteUniversity, hospital or other
Collaborators: University of the Basque Country (UPV/EHU), Osakidetza
Study start: 14 Dec 2018 (actual)
Primary completion: 19 Apr 2019 (actual)
Study completion: 27 May 2019 (actual)
First posted: 11 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AED guided	Other	Device: AEDLaypeople will be guided by an Automatic External Defibrillator's (AED) voice instructions during the cardiopulmonary resuscitation. No other help is available.
Telephone guided	Other	Device: AED, Device: TelephoneLaypeople will be guided by telephone assistance (from an Emergency Call Center) during the cardiopulmonary resuscitation. AED voice instructions are also available.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

untrained laypeople
Volunteers

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AEDInstructions provided by an AED	Device	AED guided, Telephone guided
TelephoneInstructions provided by emergency Call Center (telephonically) with the help of an AED.	Device	Telephone guided

Primary outcome

Cardiopulmonary resuscitations strated
Time frame: 9 minutes
nº of CPR strated by bystander

4 secondary outcomes

Chest compressions rate
Time frame: 9 minutes
Chest compressions depth/recoil
Time frame: 9 minutes
Time under CPR
Time frame: 8 minutes
Hands on chest
Time frame: 9 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Individual participant dataSharing planned: No

Related trials for Cardiopulmonary Resuscitation

Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AED and Telephone in people with Cardiopulmonary Resuscitation, run by Bionorte at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary resuscitations strated (time frame: 9 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03771911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.