Registry of Laypeople's CPR Performance | NCT03185260

Studies
Registry of Laypeople's CPR Performance

NCT03185260

Sponsor

Pavia nel Cuore

Status

Unknown status

Last Update Posted

Mar 4, 2020Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Quality of Cardio-pulmonary Resuscitation

Interventions

Not provided

Countries

Italy
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2016Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2020

Last Update Posted Date

Mar 4, 2020Actual

Name	Class
Robbio nel Cuore	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of adequate depth compression	Percentage of compression performed between 50 and 60 mm for each participant	1 minute

Secondary Outcomes

Measure	Description	Time Frame
Mean compression depth	Mean compression depth for each participant	1 minute
Percentage of adequate rate compression	Percentage of compression performed between 100 and 120 per minute for each participant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Layperson
Participating in a BLS/AED course carried out with feedback devices

Exclusion Criteria:

Healthcare personnel

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Enrico Baldi, MD	Contact			enrico.baldi@pavianelcuore.it
Enrico Contri, MD	Contact			enrico.contri@pavianelcuore.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robbio nel Cuore	Recruiting	Robbio	Pavia	27038	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided