NCT04774900

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

February 25, 2021

Last Update Submit

August 17, 2021

Conditions

Keywords

quality and safetyemergency medical servicesparamedicsequipmentstandardisation

Outcome Measures

Primary Outcomes (1)

  • Time

    Time from decision to execution

    Through study completion, an average of 6 months and/or until 100 cases will be collected.

Study Arms (2)

Standardised

The procedures will be observed with standardized equipment placement.

Procedure: Administration of oxygenProcedure: Administration of drug in a nebulizerProcedure: Securing intravenous lineProcedure: Administration of IV drugProcedure: Needle decompression of tension pneumothorax

Modified

The procedures will be observed with modified equipment placement - placement according to older methodology or custom.

Procedure: Administration of oxygenProcedure: Administration of drug in a nebulizerProcedure: Securing intravenous lineProcedure: Administration of IV drugProcedure: Needle decompression of tension pneumothorax

Interventions

Administration of high-flow oxygen via face mask to a high fidelity mannequin.

ModifiedStandardised

Administration of bronchodilator via nebulizer mask to a high fidelity mannequin.

ModifiedStandardised

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

ModifiedStandardised

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

ModifiedStandardised

Needle decompression of tension pneumothorax on a high fidelity mannequin.

ModifiedStandardised

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Paramedics of the Prague Emergency Medical Services - bachelor or higher professional education as paramedics.

You may qualify if:

  • consent to participate
  • times of all procedures recorded
  • all procedures provided in a correct way - in meaning of quality of the procedure

You may not qualify if:

  • disagreement with participation
  • not all procedures provided or not provided correctly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prague Emergency Medical Services

Prague, 10100, Czechia

Location

Study Officials

  • David Peran, Dr.

    Prague EMS

    STUDY CHAIR
  • Miroslav Tejkl, MS

    Prague EMS

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Education and Training Centre

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

October 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations