Out-Of-Hospital Cardiac ArrestNCT04152252
CPR Quality and Use of Feedback for OHCA
An observational study of Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the quality of cardio-pulmonary resuscitation(CPR) delivered by EMS professionals and whether this quality can be improved by implementing real-time feedback during the event and an oral post-event debriefing procedure based on the actual event performance data. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Real time feedback and Post-event debriefing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 2,989 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 31 Dec 2020
- 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 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients in OHCA in the Capital Region of Denmark who receive CPR by or under supervision of EMS professionals with the standard EMS defibrillator attached.
Who may be able to join
- OHCA
Who cannot join
- No use of EMS defibrillator attached to patient during resuscitation attempt Patients < 18 years of age OHCA without involvement of the physician manned vehicle Patients who are subject to mechanical CPR from the time of device attachment Traumatic OHCA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardio-Pulmonary-Resuscitation Quality in Out-of-Hospital Cardiac Arrest - Effect of Real-time Feedback and Post-event Debriefing
The purpose of this study is to investigate the quality of cardio-pulmonary resuscitation(CPR) delivered by EMS professionals and whether this quality can be improved by implementing real-time feedback during the event and an oral post-event debriefing procedure based on the actual event performance data.
Read the detailed description
The aim of this study is to investigate whether CPR quality can be improved by implementing real-time feedback and immediate oral structured post-event debriefing in out-of-hospital cardiac arrest (OHCA).
The objectives of this study is to assess the current quality of CPR delivered by emergency medical services (EMS) during OHCA events in the Capital Region of Denmark. Furthermore, to investigate if CPR quality can be improved by applying real-time feedback during OHCA resuscitation attempts and to investigate if structured oral post-event debriefing delivered immediately after a resuscitation attempt and based on data from the defibrillator can further improve CPR quality
The hypothesis of this study is that adding real-time and post event feedback can improve the compression rate, compression depth, overall CPR hands-on time (CPR fraction), and recoil with at least 15% in total for both interventions.
Using a prospective study design data is retrieved from the standard defibrillator (ZOLL X series) through ZOLL RescueNet® Case Review (software for post-event review, analysis, and debriefing) from ZOLL Medical Corporation, Massachusetts, United States of America.
The study consists of three consecutive phases. Phase one with no feedback / debriefing available for EMS. Phase two with real-time feedback during the event and phase three which adds post-event debriefing to real-time feedback. We expect to be able to include at least 500 cases in each phase.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Real time feedback, Post-event debriefing
- Keywords
- OHCA, Feedback, CPR quality
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time feedbackOther
Real-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate.
Post-event debriefingBehavioural
Structured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No CPR feedback during CPR | |
| Real-time feedback | Real-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate. Receives: Other: Real time feedback | |
| Post-event debriefing | Structured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes. Receives: Other: Real time feedback; Behavioral: Post-event debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest compression depth
Chest compression depth is defined as the maximum posterior deflection of the sternum prior to chest recoil. Measured in centimeters and as percentage of compressions within the recommended 5 to 6 cm
Measured: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Secondary outcomes (5)
Return of spontaneous circulation (ROSC)
The return of a spontaneous pulse prior to handover at hospital measured as events
Measured: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Sustained return of spontaneous circulation (ROSC)
The return of a spontaneous pulse at hospital handover measured as events
Measured: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
30- day survival
Patient alive at day 30 from event
Measured: 30 days from event
Chest compression rate
Chest compression rate is defined as the frequency of chest compressions during compression series. Measured in number compressions per minute (cpm) and percentage of delivered compressions within the recommended rate of 100-120 cpm
Measured: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Chest compression fraction
Chest compression fraction is defined as the time with chest compressions starting from the first therapeutic event to the end of the episode. An episode is the time without presence of a spontaneous patient pulse. Measured in percentage.
Measured: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,989 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Collaborators
- TrygFonden, Denmark, St George's, University of London, Kingston University
- Responsible party
- Principal investigator, Rasmus Meyer Lyngby, Emergency Medical Services, Capital Region, Denmark
- Investigators
- Rasmus Lyngby, BSc, Principal investigator, Emergency Medical Services, Capital Region, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152252
- Sponsor's protocol ID
- F-35103-02
- Status last verified
- Mar 2023
- First submitted
- 29 Oct 2019
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Danish legislation do not allow for sharing of individual patient data without patient consent
Publications
Lyngby RM, Quinn T, Oelrich RM, Nikoletou D, Gregers MCT, Kjolbye JS, Ersboll AK, Folke F. Association of Real-Time Feedback and Cardiopulmonary-Resuscitation Quality Delivered by Ambulance Personnel for Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2023 Oct 17;12(20):e029457. doi: 10.1161/JAHA.123.029457. Epub 2023 Oct 13.
PubMed 37830329
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-Pulmonary-Resuscitation Quality in Out-of-Hospital Cardiac Arrest - Effect of Real-time Feedback and Post-event Debriefing
- ClinicalTrials.gov ID
- NCT04152252
- Acronym / sponsor ID
- F-35103-02
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- OHCA, Feedback, CPR quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,989 participants (actual)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Collaborators
- TrygFonden, Denmark, St George's, University of London, Kingston University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Nov 2019 (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 purpose of this study is to investigate the quality of cardio-pulmonary resuscitation(CPR) delivered by EMS professionals and whether this quality can be improved by implementing real-time feedback during the event and an oral post-event debriefing procedure based on the actual event performance data.
Detailed description
The aim of this study is to investigate whether CPR quality can be improved by implementing real-time feedback and immediate oral structured post-event debriefing in out-of-hospital cardiac arrest (OHCA).
The objectives of this study is to assess the current quality of CPR delivered by emergency medical services (EMS) during OHCA events in the Capital Region of Denmark. Furthermore, to investigate if CPR quality can be improved by applying real-time feedback during OHCA resuscitation attempts and to investigate if structured oral post-event debriefing delivered immediately after a resuscitation attempt and based on data from the defibrillator can further improve CPR quality
The hypothesis of this study is that adding real-time and post event feedback can improve the compression rate, compression depth, overall CPR hands-on time (CPR fraction), and recoil with at least 15% in total for both interventions.
Using a prospective study design data is retrieved from the standard defibrillator (ZOLL X series) through ZOLL RescueNet® Case Review (software for post-event review, analysis, and debriefing) from ZOLL Medical Corporation, Massachusetts, United States of America.
The study consists of three consecutive phases. Phase one with no feedback / debriefing available for EMS. Phase two with real-time feedback during the event and phase three which adds post-event debriefing to real-time feedback. We expect to be able to include at least 500 cases in each phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | –No CPR feedback during CPR |
| Real-time feedback | – | Other: Real time feedbackReal-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate. |
| Post-event debriefing | – | Other: Real time feedback, Behavioral: Post-event debriefingStructured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in OHCA in the Capital Region of Denmark who receive CPR by or under supervision of EMS professionals with the standard EMS defibrillator attached.
Key inclusion criteria (1 listed)
- OHCA
Key exclusion criteria (1 listed)
- No use of EMS defibrillator attached to patient during resuscitation attempt Patients < 18 years of age OHCA without involvement of the physician manned vehicle Patients who are subject to mechanical CPR from the time of device attachment Traumatic OHCA
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 |
|---|---|---|
| Real time feedbackReal-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate. | Other | Post-event debriefing, Real-time feedback |
| Post-event debriefingStructured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes. | Behavioural | Post-event debriefing |
Primary outcome
Chest compression depth
Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Chest compression depth is defined as the maximum posterior deflection of the sternum prior to chest recoil. Measured in centimeters and as percentage of compressions within the recommended 5 to 6 cm
5 secondary outcomes
Return of spontaneous circulation (ROSC)
Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Sustained return of spontaneous circulation (ROSC)
Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
30- day survival
Time frame: 30 days from event
Chest compression rate
Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Chest compression fraction
Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
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 Mar 2023.
- Derived from this study: PubMed 37830329Lyngby RM, Quinn T, Oelrich RM, Nikoletou D, Gregers MCT, Kjolbye JS, Ersboll AK, Folke F. Association of Real-Time Feedback and Cardiopulmonary-Resuscitation Quality Delivered by Ambulance Personnel for Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2023 Oct 17;12(20):e029457. doi: 10.1161/JAHA.123.029457. Epub 2023 Oct 13.
- Individual participant dataSharing planned: No. Danish legislation do not allow for sharing of individual patient data without patient consent
Related trials for 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
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
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.
Rasmus Lyngby, BSc principal investigator
Emergency Medical Services, Capital Region, Denmark
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 Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
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 1 inclusion and 1 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 Mar 2023. 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 Denmark. 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?
Chest compression depth (time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04152252, which also lists 1 linked publication.
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 Mar 2023.