CPR Surface Choice on Chest Compression Quality | NCT06406101

Studies
CPR Surface Choice on Chest Compression Quality

NCT06406101

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Oct 8, 2024Actual

Enrollment

147Actual

Phase

Not Applicable

Conditions

Cardiac Arrest
Simulation of Physical Illness

Interventions

Floor
Bed

Countries

Spain

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2024Actual

Primary Completion Date

May 15, 2024Actual

Completion Date

May 15, 2024Actual

First Submitted Date

May 3, 2024

First Submission Date that Met QC Criteria

May 7, 2024

First Posted Date

May 9, 2024Actual

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

Oct 4, 2024

Last Update Posted Date

Oct 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 objective of our randomized simulation study on mannequins with a population of Basic Life Support students is to compare the quality of chest compressions, taking depth as the main variable, in two simulated scenarios of out-of-hospital cardiac arrest on a bed: one where Cardiopulmonary Resuscitation is performed on the bed and another where the patient is transferred to the ground for Cardiopulmonary Resuscitation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

147Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Floor	Experimental		Other: Floor
Bed	Active Comparator		Other: Bed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Floor	Other	Uninterrupted 2-minute chest compressions on a manikin that has been moved from the bed to the floor in a simulated scenario of out-of-hospital cardiac arrest	Floor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compressions Mean Depth	Chest Compressions Mean Depth	On the day of the simulation

Secondary Outcomes

Measure	Description	Time Frame
Time to first chest compression	The time it takes to initiate chest compressions.	On the day of the simulation
Effectiveness of Chest Compressions	Global Punctuation of Chest Compressions in Skillreporter app.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those individuals who sign the informed consent and do not meet exclusion criteria

Exclusion Criteria: Individuals with any limitation or contraindication for physical exercise:

Arthritis
Heart disease
Advanced lung disease
Severe physical disability
Morbid obesity
Chronic fatigue
Pregnancy

Withdrawal Criteria:

Those individuals who, due to limitations in physical exercise, do not reach 2 minutes of compressions
Students who have not obtained the certificate of successfully completing the course.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adriana Capdevila, MD	Hospital Clinic Barcelona, Universitat de Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic Barcelona		Barcelona		08036	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D005430	Floors and Floorcoverings
D001513	Beds

Ancestor Terms

ID	Term
D005160	Facility Design and Construction
D001108	Architecture
D013676	Technology, Industry, and Agriculture
D004865	Equipment and Supplies, Hospital

Browse Leaves

Not provided

Browse Branches

Not provided