- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06406101
CPR Surface Choice on Chest Compression Quality
October 4, 2024 updated by: Enrique Carrero, Hospital Clinic of Barcelona
Influence of CPR Surface Choice on Chest Compression Quality: A Randomized Manikin Study Comparing Bed and Floor Settings
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
147
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic Barcelona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Floor
|
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
|
|
Active Comparator: Bed
|
Uninterrupted 2-minute chest compressions on a manikin that is laying on bed in a simulated scenario of out-of-hospital cardiac arrest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compressions Mean Depth
Time Frame: On the day of the simulation
|
Chest Compressions Mean Depth
|
On the day of the simulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first chest compression
Time Frame: On the day of the simulation
|
The time it takes to initiate chest compressions.
|
On the day of the simulation
|
|
Effectiveness of Chest Compressions
Time Frame: On the day of the simulation
|
Global Punctuation of Chest Compressions in Skillreporter app.
|
On the day of the simulation
|
|
Total number of chest compressions
Time Frame: 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)
Time Frame: On the day of the simulation
|
Percentage of compressions whit correct depth (5-6cm)
|
On the day of the simulation
|
|
Mean frequency of chest compressions
Time Frame: On the day of the simulation
|
Mean frequency of chest compressions
|
On the day of the simulation
|
|
Percentage of chest compressions with correct frequency
Time Frame: On the day of the simulation
|
Percentage of chest compressions with correct frequency
|
On the day of the simulation
|
|
Percentage of chest compressions with correct position of hands
Time Frame: On the day of the simulation
|
Percentage of chest compressions with correct position of hands
|
On the day of the simulation
|
|
Percentage of chest compressions with correct release
Time Frame: On the day of the simulation
|
Percentage of chest compressions with correct release
|
On the day of the simulation
|
|
Borg Scale for Fatigability
Time Frame: On the day of the simulation
|
The scale includes a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort.
|
On the day of the simulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adriana Capdevila, MD, Hospital Clinic Barcelona, Universitat de Barcelona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2024
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
May 15, 2024
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 7, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
October 8, 2024
Last Update Submitted That Met QC Criteria
October 4, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCBCPR_24147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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