NCT06406101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 8, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

7 days

First QC Date

May 3, 2024

Last Update Submit

October 4, 2024

Conditions

Keywords

Cardiopulmonary ResuscitationCardiac arrestSimulation studyChest Compressions

Outcome Measures

Primary Outcomes (1)

  • Compressions Mean Depth

    Chest Compressions Mean Depth

    On the day of the simulation

Secondary Outcomes (9)

  • Time to first chest compression

    On the day of the simulation

  • Effectiveness of Chest Compressions

    On the day of the simulation

  • Total number of chest compressions

    On the day of the simulation

  • Percentage of chest compressions whit correct depth (5-6cm)

    On the day of the simulation

  • Mean frequency of chest compressions

    On the day of the simulation

  • +4 more secondary outcomes

Study Arms (2)

Floor

EXPERIMENTAL
Other: Floor

Bed

ACTIVE COMPARATOR
Other: Bed

Interventions

FloorOTHER

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
BedOTHER

Uninterrupted 2-minute chest compressions on a manikin that is laying on bed in a simulated scenario of out-of-hospital cardiac arrest

Bed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Floors and FloorcoveringsBeds

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Facility Design and ConstructionArchitectureTechnology, Industry, and AgricultureEquipment and Supplies, HospitalEquipment and Supplies

Study Officials

  • Adriana Capdevila, MD

    Hospital Clinic Barcelona, Universitat de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 9, 2024

Study Start

May 8, 2024

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations