Cardiopulmonary ResuscitationNCT04357548
Optimization of Quality in Cardiopulmonary Resuscitation Through Monitor-defibrillator With Feedback System
An observational study of Cardiopulmonary Resuscitation, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
AIM: To verify the effect of a feedback system on optimizing quality during CPR on mannequins. Hypothesis: The quality of CPR performed by healthcare professionals through a defibrillator monitor with a feedback system is higher than those that do not use a feedback system on a manikin. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- FEEDBACK
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 17 Oct 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects belonging to the General Emergency Department of the Hospital Clinico Universitario Virgen de la Arrixaca corresponding with doctors, resident doctors and nurses who are working in the service during the study period and receive the training session on CPR quality and the use of the defibrillator monitor with feedback system
Who may be able to join
- Health professionals working in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period. They include doctors, resident doctors, and nurses.
- Health professionals from the General Emergency Service of the Virgen de la Arrixaca University Hospital who receive the training session on CPR quality and use of the defibrillator monitor with feedback system.
Who cannot join
- Health professionals who do not work in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period.
- Health professionals who work in the General Emergency Service of the Virgen de la Arrixaca University Hospital and refuse to carry out the training and demonstration session.
Trial locations and contacts
1 site in 1 country.
About this study
AIM: To verify the effect of a feedback system on optimizing quality during CPR on mannequins.
Hypothesis: The quality of CPR performed by healthcare professionals through a defibrillator monitor with a feedback system is higher than those that do not use a feedback system on a manikin.
Read more
METHOD Type of study: Pre-experimental with pretest-postest design. Sample: Health professionals of the General Emergency Service of the Virgen de la Arrixaca University Hospital (HCUVA).
Sampling type: Non-probabilistic for convenience. Variables: sex, age, profession, years of experience, last CPR training received, last time performing CPR, depth, frequency, quality CPR, perception of the quality of CPR.
Statistical analysis: Student's t for related samples and McNemar.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- FEEDBACK
- Keywords
- Cardiopulmonary Resuscitation, Feedback, Quality Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEEDBACKDevice
Once the sample was selected, a test was performed in which the professionals performed 2 minutes of CPR on the dummy without any feedback system, after 5 minutes they performed 2 minutes of CPR with feedback system through the Zoll® monitor with CPR patch -D padz training, to later compare the pretest-posttest results.
| Study group | Role | What they receive |
|---|---|---|
| Feedback system | Once the sample was selected, a test was performed in which the professionals performed 2 minutes of CPR on the dummy without any feedback system, after 5 minutes they performed 2 minutes of CPR with feedback system through the Zoll® monitor with CPR patch -D padz training, to later compare the pretest-posttest results. Receives: Device: FEEDBACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth compression
Depth of chest compressions performed by the subject
Measured: 2 minutes
Rate compression
Frequency of the number of chest compressions per minute performed by the subject
Measured: 2 minutes
Quality CPR
Total quality of the cardiopulmonary resuscitation performed by the subject
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Collaborators
- Zoll Medical Corporation
- Responsible party
- Principal investigator, JOSE ANTONIO JIMENEZ HERNANDEZ, Hospital Universitario Virgen de la Arrixaca
- Investigators
- Jose Antonio Jimenez Hernandez, Doctor, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357548
- Sponsor's protocol ID
- OPTIMUMCPR
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Quality in Cardiopulmonary Resuscitation Through Monitor-defibrillator With Feedback System
- ClinicalTrials.gov ID
- NCT04357548
- Acronym / sponsor ID
- OPTIMUMCPR
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- Cardiopulmonary Resuscitation, Feedback, Quality Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Collaborators
- Zoll Medical Corporation
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 22 Apr 2020 (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.
AIM: To verify the effect of a feedback system on optimizing quality during CPR on mannequins.
Hypothesis: The quality of CPR performed by healthcare professionals through a defibrillator monitor with a feedback system is higher than those that do not use a feedback system on a manikin.
METHOD Type of study: Pre-experimental with pretest-postest design. Sample: Health professionals of the General Emergency Service of the Virgen de la Arrixaca University Hospital (HCUVA).
Sampling type: Non-probabilistic for convenience. Variables: sex, age, profession, years of experience, last CPR training received, last time performing CPR, depth, frequency, quality CPR, perception of the quality of CPR.
Statistical analysis: Student's t for related samples and McNemar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feedback system | – | Device: FEEDBACKOnce the sample was selected, a test was performed in which the professionals performed 2 minutes of CPR on the dummy without any feedback system, after 5 minutes they performed 2 minutes of CPR with feedback system through the Zoll® monitor with CPR patch -D padz training, to later compare the pretest-posttest results. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects belonging to the General Emergency Department of the Hospital Clinico Universitario Virgen de la Arrixaca corresponding with doctors, resident doctors and nurses who are working in the service during the study period and receive the training session on CPR quality and the use of the defibrillator monitor with feedback system
Key inclusion criteria (2 listed)
- Health professionals working in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period. They include doctors, resident doctors, and nurses.
- Health professionals from the General Emergency Service of the Virgen de la Arrixaca University Hospital who receive the training session on CPR quality and use of the defibrillator monitor with feedback system.
Key exclusion criteria (2 listed)
- Health professionals who do not work in the General Emergency Service of the Virgen de la Arrixaca University Clinical Hospital during the study period.
- Health professionals who work in the General Emergency Service of the Virgen de la Arrixaca University Hospital and refuse to carry out the training and demonstration session.
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 |
|---|---|---|
| FEEDBACKOnce the sample was selected, a test was performed in which the professionals performed 2 minutes of CPR on the dummy without any feedback system, after 5 minutes they performed 2 minutes of CPR with feedback system through the Zoll® monitor with CPR patch -D padz training, to later compare the pretest-posttest results. | Device | Feedback system |
Primary outcome
Depth compression
Time frame: 2 minutes
Depth of chest compressions performed by the subject
Rate compression
Time frame: 2 minutes
Frequency of the number of chest compressions per minute performed by the subject
Quality CPR
Time frame: 2 minutes
Total quality of the cardiopulmonary resuscitation performed by the subject
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 22 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Resuscitation
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
Jose Antonio Jimenez Hernandez, Doctor principal investigator
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Resuscitation, run by Hospital Universitario Virgen de la Arrixaca 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 2 inclusion and 2 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 22 Apr 2020. 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?
Depth compression (time frame: 2 minutes). The study lists 3 primary outcomes in all. 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 22 Apr 2020.