Cardiac ArrestNCT06406101
CPR Surface Choice on Chest Compression Quality
A study testing Floor and Bed in people with Cardiac Arrest and Simulation of Physical Illness, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Simulation of Physical Illness
- What is being tested?
- Floor and Bed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2024to 15 May 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiac Arrest, Simulation of Physical Illness
- Being tested
- Floor, Bed
- Keywords
- Cardiopulmonary Resuscitation, Cardiac arrest, Simulation study, Chest Compressions
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
BedOther
Uninterrupted 2-minute chest compressions on a manikin that is laying on bed in a simulated scenario of out-of-hospital cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| Floor | Experimental | Not described Receives: Other: Floor |
| Bed | Active comparator | Not described Receives: Other: Bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compressions Mean Depth
Chest Compressions Mean Depth
Measured: On the day of the simulation
Secondary outcomes (9)
Time to first chest compression
The time it takes to initiate chest compressions.
Measured: On the day of the simulation
Effectiveness of Chest Compressions
Global Punctuation of Chest Compressions in Skillreporter app.
Measured: On the day of the simulation
Total number of chest compressions
Total number of chest compressions
Measured: On the day of the simulation
Percentage of chest compressions whit correct depth (5-6cm)
Percentage of compressions whit correct depth (5-6cm)
Measured: On the day of the simulation
Mean frequency of chest compressions
Mean frequency of chest compressions
Measured: On the day of the simulation
Percentage of chest compressions with correct frequency
Percentage of chest compressions with correct frequency
Measured: On the day of the simulation
Percentage of chest compressions with correct position of hands
Percentage of chest compressions with correct position of hands
Measured: On the day of the simulation
Percentage of chest compressions with correct release
Percentage of chest compressions with correct release
Measured: On the day of the simulation
Borg Scale for Fatigability
The scale includes a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort.
Measured: On the day of the simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start8 May 2024
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Carrero, Hospital Clinic of Barcelona
- Investigators
- Adriana Capdevila, MD, Principal investigator, Hospital Clinic Barcelona, Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406101
- Sponsor's protocol ID
- HCBCPR_24147
- Status last verified
- Oct 2024
- First submitted
- 3 May 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of CPR Surface Choice on Chest Compression Quality: A Randomized Manikin Study Comparing Bed and Floor Settings
- ClinicalTrials.gov ID
- NCT06406101
- Acronym / sponsor ID
- HCBCPR_24147
- Conditions
- Cardiac Arrest, Simulation of Physical Illness
- Keywords
- Cardiopulmonary Resuscitation, Cardiac arrest, Simulation study, Chest Compressions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 9 May 2024 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Floor | Experimental | Other: Floor |
| Bed | Active comparator | Other: Bed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FloorUninterrupted 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 | Other | Floor |
| BedUninterrupted 2-minute chest compressions on a manikin that is laying on bed in a simulated scenario of out-of-hospital cardiac arrest | Other | Bed |
Primary outcome
Compressions Mean Depth
Time frame: On the day of the simulation
Chest Compressions Mean Depth
9 secondary outcomes
Time to first chest compression
Time frame: On the day of the simulation
Effectiveness of Chest Compressions
Time frame: On the day of the simulation
Total number of chest compressions
Time frame: On the day of the simulation
Percentage of chest compressions whit correct depth (5-6cm)
Time frame: On the day of the simulation
Mean frequency of chest compressions
Time frame: 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 position of hands
Time frame: On the day of the simulation
Percentage of chest compressions with correct release
Time frame: On the day of the simulation
Borg Scale for Fatigability
Time frame: On the day of the simulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Adriana Capdevila, MD principal investigator
Hospital Clinic Barcelona, Universitat de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floor and Bed in people with Cardiac Arrest and Simulation of Physical Illness, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 12 inclusion and 0 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: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compressions Mean Depth (time frame: On the day of the simulation). 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 8 Oct 2024.