- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05113706
Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary?Resuscitation
Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary Resuscitation?
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ballerup
-
Copenhagen, Ballerup, Denmark, 2750
- Copenhagen Emergency Medical Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All emergency call recordings involving OHCA in the capital region of Denmark in the time period 01.09.2018 - 01.11.2019
Exclusion Criteria:
- Emergency medical services (EMS)-witnessed OHCA
- Missing emergency call recording
- Caller not physically by patient's site
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first compression
Time Frame: 0-15 minutes
|
Time from the emergency call starts to first chest compression
|
0-15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to to recognition of cardiac arrest
Time Frame: 0-15 minuts
|
Time from the emergency call starts to recognition of cardiac arrest
|
0-15 minuts
|
|
Dispatcher encouraging when giving instructions
Time Frame: 0-15 minuts
|
Was the medical dispatcher motivating and encouraging when giving instructions (Yes/No)
|
0-15 minuts
|
|
Dispatcher assertive or passive when giving instructions
Time Frame: 0-15 minuts
|
Was the medical dispatcher assertive or passive when giving instructions (Yes/No)
|
0-15 minuts
|
|
Dispatcher instruct on depth and speed of compressions
Time Frame: 0-15 minuts
|
Did the medical dispatcher instruct on depth and speed of compressions (Yes/No)
|
0-15 minuts
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gitte Linderoth, PhD, Copenhagen Emergency Medical Services
- Study Chair: Fredrik Folke, PhD, Prof, Copenhagen Emergency Medical Services
- Study Chair: Annette Ersbøll, PhD, Prof, National Institute of Public Health, University of Southern Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F35150-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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