- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774900
Standardization of Ambulance Equipment
August 17, 2021 updated by: David Peran
The Influence of Standardization of Ambulance Equipment on the Speed of Medical Procedures Provision
The aim of the research is to find out what effect the standardization of ambulance equipment has on the speed of performing specific medical procedures.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
The aim of the research is to find out what effect the standardization of ambulance equipment has on the speed of performing specific medical procedures.
In two simulated scenarios, the times from the decision to execution of medical procedures will be measured.
In the first scenario, the equipment is located in the standard way and the research participants know where it is located.
In the second scenario, the equipment is placed elsewhere and participants do not have the opportunity to check the equipment before the scenario.
For the statistical comparison the Student's T-test and Wilcoxon signed-rank test will be used.
For analysis of variance will be used the ANOVA test and for more than two dependent selections the Friedman's ANOVA test will be used.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David Peran, Dr.
- Phone Number: 00420 602 611 746
- Email: David.Peran@zzshmp.cz
Study Contact Backup
- Name: Jaroslav Pekara, Ph.D.
- Phone Number: 00420 737 127 508
- Email: jaroslav.pekara@zzshmp.cz
Study Locations
-
-
-
Praha, Czechia, 10100
- Prague Emergency Medical Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Paramedics of the Prague Emergency Medical Services - bachelor or higher professional education as paramedics.
Description
Inclusion Criteria:
- consent to participate
- times of all procedures recorded
- all procedures provided in a correct way - in meaning of quality of the procedure
Exclusion Criteria:
- disagreement with participation
- not all procedures provided or not provided correctly
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Standardised
The procedures will be observed with standardized equipment placement.
|
Administration of high-flow oxygen via face mask to a high fidelity mannequin.
Administration of bronchodilator via nebulizer mask to a high fidelity mannequin.
Securing an intravenous line at the forearm of high fidelity mannequin.
Administration of bronchodilator via IV line to a high fidelity mannequin.
Needle decompression of tension pneumothorax on a high fidelity mannequin.
|
|
Modified
The procedures will be observed with modified equipment placement - placement according to older methodology or custom.
|
Administration of high-flow oxygen via face mask to a high fidelity mannequin.
Administration of bronchodilator via nebulizer mask to a high fidelity mannequin.
Securing an intravenous line at the forearm of high fidelity mannequin.
Administration of bronchodilator via IV line to a high fidelity mannequin.
Needle decompression of tension pneumothorax on a high fidelity mannequin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time
Time Frame: Through study completion, an average of 6 months and/or until 100 cases will be collected.
|
Time from decision to execution
|
Through study completion, an average of 6 months and/or until 100 cases will be collected.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: David Peran, Dr., Prague EMS
- Study Director: Miroslav Tejkl, MS, Prague EMS
- Principal Investigator: Roman Sýkora, Ph.D., EMS of Karlovy Vary Region
- Principal Investigator: Metodej Renza, MD, 3rd Faculty of Medicine, Charles University in Prague
- Principal Investigator: Jaroslav Pekara, Ph.D., Prague EMS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2021
Primary Completion (Anticipated)
November 30, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
March 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 18, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ZZSHMP_002_2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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