Out-Of-Hospital Cardiac ArrestNCT05113706
Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary?Resuscitation
An observational study of Out-Of-Hospital Cardiac Arrest and Emotional Distress, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
Trial summary
The study aims to investigate bystanders' emotional stress state in out-of-hospital cardiac arrest (OHCA) emergency calls and the association with the quality of dispatcher-assisted cardiopulmonary resuscitation (DA-CPR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Emotional Distress
- How many people
- 1,100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 10 Mar 2022
- 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
- Child, Adult, Older adult
Study population: Bystander who call the emergency number in case of OHCA
Who may be able to join
- All emergency call recordings involving OHCA in the capital region of Denmark in the time period 01.09.2018 - 01.11.2019
Who cannot join
- Emergency medical services (EMS)-witnessed OHCA
- Missing emergency call recording
- Caller not physically by patient's site
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Emergency Medical Services
Copenhagen, Ballerup, 2750
About this study
Official title: Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary Resuscitation?
The study aims to investigate bystanders' emotional stress state in out-of-hospital cardiac arrest (OHCA) emergency calls and the association with the quality of dispatcher-assisted cardiopulmonary resuscitation (DA-CPR).
Read the detailed description
Delayed CPR is believed to be an important factor in the outcome of out-of-hospital cardiac arrest (OHCA). Bystanders' emotional stress state might affect recognition of cardiac arrest and the resuscitation attempt. The study aims to investigate the association between a bystander's emotional stress state at the beginning of the emergency call in out-of-hospital cardiac arrest (OHCA) and dispatcher-assisted cardiopulmonary resuscitation (DA-CPR).
Method
The study is a retrospective and observational study of OHCA emergency calls from the capital region of Denmark from 01.09.2018 - 01.11.2019. The audio recordings of the emergency calls will be obtained from the emergency medical service database. A code catalogue with standardised default descriptions to each variable will be used. The study will only include the first person whom the medical dispatcher talk to. The rating of the calls will be performed by five observers outside of the research group, who have no conflict of interest.
The primary outcome of the present study will be to investigate an association between a bystander's emotional stress state in the beginning of the emergency call of OHCA and the time until first chest compression. Secondarily, the study investigated the association between the bystander's emotional stress and:
Outcome variables:
- Time to recognition of OHCA, time to initiate CPR, and time to first compression.
- Assessment of OHCA by the medical dispatcher (Does the dispatcher address patient breathing status and consciousness) (Yes/No)
- The quality of DA-CPR instructions:
- Was the medical dispatcher motivating and encouraging when giving instructions (Yes/No)
- Was the medical dispatcher assertive or passive when giving instructions (Yes/No)
- Did the medical dispatcher instruct on depth and speed of compressions (Yes/No) Information about caller such as gender and relationship to the patient will also be included in the analyse.
Descriptive analysis of baseline characteristics of emergency calls and dispatchers will be performed by frequency distributions (N %) stratified by emotional stress.
Investigators will use logistic regression on categorical variables to analyse differences in the quality of DA-CPR based on the emotional stress state.
Wilcoxon rank-sum test will be used on non-normally distributed continuous variables to analyse differences in time until first chest compression. Two-way ANOVA will be used to analyse the mean of quantitative variables according to the levels of categorical variables. Furthermore, failure analysis was used to analyse and visualise differences in time until chest compressions based on the emotional stress state.
Kappa statistics were used to assess inter-rater variability and agreement between the reviewers. A Kappa score of overall agreement of 0.72% was found, which provides a substantial agreement between the raters.
- Conditions
- Out-Of-Hospital Cardiac Arrest, Emotional Distress
- Keywords
- Dispatcher, Emergency call, Out-Of-Hospital Cardiac Arrest
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Bystander not emotional distressed | If caller is not emotional distressed the first minute of the call | |
| Bystander emotional distressed | If caller is emotional distressed the first minute of the call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first compression
Time from the emergency call starts to first chest compression
Measured: 0-15 minutes
Secondary outcomes (4)
Time to to recognition of cardiac arrest
Time from the emergency call starts to recognition of cardiac arrest
Measured: 0-15 minuts
Dispatcher encouraging when giving instructions
Was the medical dispatcher motivating and encouraging when giving instructions (Yes/No)
Measured: 0-15 minuts
Dispatcher assertive or passive when giving instructions
Was the medical dispatcher assertive or passive when giving instructions (Yes/No)
Measured: 0-15 minuts
Dispatcher instruct on depth and speed of compressions
Did the medical dispatcher instruct on depth and speed of compressions (Yes/No)
Measured: 0-15 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Sep 2018
- Primary completion10 Mar 2022 (estimated)
- Study completion10 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gitte Linderoth, PhD, Principal investigator, Copenhagen Emergency Medical ServicesFredrik Folke, PhD, Prof, Study chair, Copenhagen Emergency Medical ServicesAnnette Ersbøll, PhD, Prof, Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113706
- Sponsor's protocol ID
- F35150-04
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary Resuscitation?
- ClinicalTrials.gov ID
- NCT05113706
- Acronym / sponsor ID
- F35150-04
- Conditions
- Out-Of-Hospital Cardiac Arrest, Emotional Distress
- Keywords
- Dispatcher, Emergency call, Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 Mar 2022 (estimated)
- Study completion
- 10 Mar 2022 (estimated)
- First posted
- 9 Nov 2021 (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 study aims to investigate bystanders' emotional stress state in out-of-hospital cardiac arrest (OHCA) emergency calls and the association with the quality of dispatcher-assisted cardiopulmonary resuscitation (DA-CPR).
Detailed description
Delayed CPR is believed to be an important factor in the outcome of out-of-hospital cardiac arrest (OHCA). Bystanders' emotional stress state might affect recognition of cardiac arrest and the resuscitation attempt. The study aims to investigate the association between a bystander's emotional stress state at the beginning of the emergency call in out-of-hospital cardiac arrest (OHCA) and dispatcher-assisted cardiopulmonary resuscitation (DA-CPR).
Method
The study is a retrospective and observational study of OHCA emergency calls from the capital region of Denmark from 01.09.2018 - 01.11.2019. The audio recordings of the emergency calls will be obtained from the emergency medical service database. A code catalogue with standardised default descriptions to each variable will be used. The study will only include the first person whom the medical dispatcher talk to. The rating of the calls will be performed by five observers outside of the research group, who have no conflict of interest.
The primary outcome of the present study will be to investigate an association between a bystander's emotional stress state in the beginning of the emergency call of OHCA and the time until first chest compression. Secondarily, the study investigated the association between the bystander's emotional stress and:
Outcome variables:
- Time to recognition of OHCA, time to initiate CPR, and time to first compression.
- Assessment of OHCA by the medical dispatcher (Does the dispatcher address patient breathing status and consciousness) (Yes/No)
- The quality of DA-CPR instructions:
- Was the medical dispatcher motivating and encouraging when giving instructions (Yes/No)
- Was the medical dispatcher assertive or passive when giving instructions (Yes/No)
- Did the medical dispatcher instruct on depth and speed of compressions (Yes/No) Information about caller such as gender and relationship to the patient will also be included in the analyse.
Descriptive analysis of baseline characteristics of emergency calls and dispatchers will be performed by frequency distributions (N %) stratified by emotional stress.
Investigators will use logistic regression on categorical variables to analyse differences in the quality of DA-CPR based on the emotional stress state.
Wilcoxon rank-sum test will be used on non-normally distributed continuous variables to analyse differences in time until first chest compression. Two-way ANOVA will be used to analyse the mean of quantitative variables according to the levels of categorical variables. Furthermore, failure analysis was used to analyse and visualise differences in time until chest compressions based on the emotional stress state.
Kappa statistics were used to assess inter-rater variability and agreement between the reviewers. A Kappa score of overall agreement of 0.72% was found, which provides a substantial agreement between the raters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bystander not emotional distressed | – | –If caller is not emotional distressed the first minute of the call |
| Bystander emotional distressed | – | –If caller is emotional distressed the first minute of the call |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Bystander who call the emergency number in case of OHCA
Key inclusion criteria (1 listed)
- All emergency call recordings involving OHCA in the capital region of Denmark in the time period 01.09.2018 - 01.11.2019
Key exclusion criteria (3 listed)
- Emergency medical services (EMS)-witnessed OHCA
- Missing emergency call recording
- Caller not physically by patient's site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to first compression
Time frame: 0-15 minutes
Time from the emergency call starts to first chest compression
4 secondary outcomes
Time to to recognition of cardiac arrest
Time frame: 0-15 minuts
Dispatcher encouraging when giving instructions
Time frame: 0-15 minuts
Dispatcher assertive or passive when giving instructions
Time frame: 0-15 minuts
Dispatcher instruct on depth and speed of compressions
Time frame: 0-15 minuts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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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.
Gitte Linderoth, PhD principal investigator
Copenhagen Emergency Medical Services
Fredrik Folke, PhD, Prof study chair
Copenhagen Emergency Medical Services
Annette Ersbøll, PhD, Prof study chair
University of Southern 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 and Emotional Distress, 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 3 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. 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?
Results are not available in the source record.
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?
Time to first compression (time frame: 0-15 minutes). 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 14 Mar 2022.