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Standardization of Ambulance Equipment

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ClinicalTrials.gov Identifier: NCT04774900
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
David Peran, Emergency Medical Service, Prague

Brief Summary:
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.

Condition or disease Intervention/treatment
Safety Issues Procedure: Administration of oxygen Procedure: Administration of drug in a nebulizer Procedure: Securing intravenous line Procedure: Administration of IV drug Procedure: Needle decompression of tension pneumothorax

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Standardization of Ambulance Equipment on the Speed of Medical Procedures Provision
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort Intervention/treatment
Standardised
The procedures will be observed with standardized equipment placement.
Procedure: Administration of oxygen
Administration of high-flow oxygen via face mask to a high fidelity mannequin.

Procedure: Administration of drug in a nebulizer
Administration of bronchodilator via nebulizer mask to a high fidelity mannequin.

Procedure: Securing intravenous line
Securing an intravenous line at the forearm of high fidelity mannequin.

Procedure: Administration of IV drug
Administration of bronchodilator via IV line to a high fidelity mannequin.

Procedure: Needle decompression of tension pneumothorax
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.
Procedure: Administration of oxygen
Administration of high-flow oxygen via face mask to a high fidelity mannequin.

Procedure: Administration of drug in a nebulizer
Administration of bronchodilator via nebulizer mask to a high fidelity mannequin.

Procedure: Securing intravenous line
Securing an intravenous line at the forearm of high fidelity mannequin.

Procedure: Administration of IV drug
Administration of bronchodilator via IV line to a high fidelity mannequin.

Procedure: Needle decompression of tension pneumothorax
Needle decompression of tension pneumothorax on a high fidelity mannequin.




Primary Outcome Measures :
  1. Time [ Time Frame: Through study completion, an average of 6 months and/or until 100 cases will be collected. ]
    Time from decision to execution



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Paramedics of the Prague Emergency Medical Services - bachelor or higher professional education as paramedics.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774900


Contacts
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Contact: David Peran, Dr. 00420 602 611 746 David.Peran@zzshmp.cz
Contact: Jaroslav Pekara, Ph.D. 00420 737 127 508 jaroslav.pekara@zzshmp.cz

Locations
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Czechia
Prague Emergency Medical Services
Praha, Czechia, 10100
Sponsors and Collaborators
David Peran
Investigators
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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
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Responsible Party: David Peran, Head of Education and Training Centre, Emergency Medical Service, Prague
ClinicalTrials.gov Identifier: NCT04774900    
Other Study ID Numbers: ZZSHMP_002_2021
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Peran, Emergency Medical Service, Prague:
quality and safety
emergency medical services
paramedics
equipment
standardisation