Quality of Cardio-pulmonary ResuscitationNCT03185260
Registry of Laypeople's CPR Performance
An observational study of Quality of Cardio-pulmonary Resuscitation, run by Pavia nel Cuore at 5 sites in 2 countries.
Trial summary
The aim of the registry is to collect laypeople's performance after a BLS/AED course carried out with the use of feedback devices. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Cardio-pulmonary Resuscitation
- How many people
- 10,000 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 May 2016to 31 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the layperson between 18 and 90 years who participate to a BLS/AED course carried out with the use of feedback devices for at least one minute in one of the centers which joined the registry
Who may be able to join
- Layperson
- Participating in a BLS/AED course carried out with feedback devices
Who cannot join
- Healthcare personnel
Trial locations and contacts
5 sites in 2 countries.
Enrico Baldi, MD contact
Enrico Contri, MD contact
5 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Policlinico P. Giaccone
Palermo, 90127
Andrea Cortegiani, MD, cortegiania@gmail.com
Iozzo Pasquale, MD
- Recruiting
Pavia nel Cuore
Pavia, 27100
Enrico Contri, MD, enrico.contri@pavianelcuore.it
- Recruiting
Robbio nel Cuore
Robbio, Pavia, 27038
Enrico Baldi, MD, info@robbionelcuore.it
Switzerland2 sites, 2 recruiting
- Recruiting
FormaMed
Cortaillod, 2016
Micheal Terrapon, michael.terrapon@formamed.ch
- Recruiting
ES ASUR
Le Mont-sur-Lausanne, 1052
Sandrine Denereaz, info@es-asur.ch
About this study
Official title: International Registry of Laypeople's CPR Performance After Training With Feedback Devices
The aim of the registry is to collect laypeople's performance after a BLS/AED course carried out with the use of feedback devices.
Read the detailed description
The registry collect all the laypeople's performance of 1-minute of chest-compression only CPR registered at the end of a CPR/AED course in which feedback devices were used for at least 1 minute.
All centers which carry out BLS/AED course for laypeople using CPR feedback devices can join to the registry.
All the centers have to declare the duration of the course, the guidelines followed, the participants' anthropometric variables and the feedback device they used for the course and for the test.
The centers must send the performances of all the participants of a course.
- Keywords
- Cardio-Pulmonary Resuscitation, Cardiac Arrest, Training
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adequate depth compression
Percentage of compression performed between 50 and 60 mm for each participant
Measured: 1 minute
Secondary outcomes (5)
Mean compression depth
Mean compression depth for each participant
Measured: 1 minute
Percentage of adequate rate compression
Percentage of compression performed between 100 and 120 per minute for each participant
Measured: 1 minute
Compression per minute
Number of compressions per minute
Measured: 1 minute
Percentage of correctly released compression
Percentage of compressions performed with complete chest recoil
Measured: 1 minute
Percentage of correct hand position
Percentage of compressions performed with hands in the correct position
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 May 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Cardio-pulmonary 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pavia nel Cuore
- Sponsor type
- University, hospital or other
- Collaborators
- Robbio nel Cuore
- Responsible party
- Principal investigator, Enrico Baldi, Pavia nel Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185260
- Sponsor's protocol ID
- FeedbackRegistry
- Status last verified
- Mar 2020
- First submitted
- 9 Jun 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry of Laypeople's CPR Performance After Training With Feedback Devices
- ClinicalTrials.gov ID
- NCT03185260
- Acronym / sponsor ID
- FeedbackRegistry
- Keywords
- Cardio-Pulmonary Resuscitation, Cardiac Arrest, Training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Pavia nel CuoreUniversity, hospital or other
- Collaborators
- Robbio nel Cuore
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (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.
The aim of the registry is to collect laypeople's performance after a BLS/AED course carried out with the use of feedback devices.
Detailed description
The registry collect all the laypeople's performance of 1-minute of chest-compression only CPR registered at the end of a CPR/AED course in which feedback devices were used for at least 1 minute.
All centers which carry out BLS/AED course for laypeople using CPR feedback devices can join to the registry.
All the centers have to declare the duration of the course, the guidelines followed, the participants' anthropometric variables and the feedback device they used for the course and for the test.
The centers must send the performances of all the participants of a course.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the layperson between 18 and 90 years who participate to a BLS/AED course carried out with the use of feedback devices for at least one minute in one of the centers which joined the registry
Key inclusion criteria (2 listed)
- Layperson
- Participating in a BLS/AED course carried out with feedback devices
Key exclusion criteria (1 listed)
- Healthcare personnel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of adequate depth compression
Time frame: 1 minute
Percentage of compression performed between 50 and 60 mm for each participant
5 secondary outcomes
Mean compression depth
Time frame: 1 minute
Percentage of adequate rate compression
Time frame: 1 minute
Compression per minute
Time frame: 1 minute
Percentage of correctly released compression
Time frame: 1 minute
Percentage of correct hand position
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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.
Enrico Baldi, MD contact
Enrico Contri, MD contact
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Cardio-pulmonary Resuscitation, run by Pavia nel Cuore at 5 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico Baldi, MD (enrico.baldi@pavianelcuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adequate depth compression (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2020.