Safety IssuesNCT04774900
Standardization of Ambulance Equipment
An observational study of Safety Issues, run by David Peran at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Administration of oxygen, Administration of drug in a nebulizer and Securing intravenous line
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2021to 31 Dec 2021
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Paramedics of the Prague Emergency Medical Services - bachelor or higher professional education as paramedics.
Who may be able to join
- consent to participate
- times of all procedures recorded
- all procedures provided in a correct way - in meaning of quality of the procedure
Who cannot join
- disagreement with participation
- not all procedures provided or not provided correctly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- Administration of oxygen, Administration of drug in a nebulizer, Securing intravenous line, Administration of IV drug, Needle decompression of tension pneumothorax
- Keywords
- quality and safety, emergency medical services, paramedics, equipment, standardisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of oxygenProcedure or surgery
Administration of high-flow oxygen via face mask to a high fidelity mannequin.
Administration of drug in a nebulizerProcedure or surgery
Administration of bronchodilator via nebulizer mask to a high fidelity mannequin.
Securing intravenous lineProcedure or surgery
Securing an intravenous line at the forearm of high fidelity mannequin.
Administration of IV drugProcedure or surgery
Administration of bronchodilator via IV line to a high fidelity mannequin.
Needle decompression of tension pneumothoraxProcedure or surgery
Needle decompression of tension pneumothorax on a high fidelity mannequin.
| Study group | Role | What they receive |
|---|---|---|
| Standardised | The procedures will be observed with standardized equipment placement. Receives: 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 | |
| Modified | The procedures will be observed with modified equipment placement - placement according to older methodology or custom. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Time from decision to execution
Measured: Through study completion, an average of 6 months and/or until 100 cases will be collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Peran
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, David Peran, Emergency Medical Service, Prague
- Investigators
- David Peran, Dr., Study chair, Prague EMSMiroslav Tejkl, MS, Study director, Prague EMSRoman Sýkora, Ph.D., Principal investigator, EMS of Karlovy Vary RegionMetodej Renza, MD, Principal investigator, 3rd Faculty of Medicine, Charles University in PragueJaroslav Pekara, Ph.D., Principal investigator, Prague EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774900
- Sponsor's protocol ID
- ZZSHMP_002_2021
- Status last verified
- Aug 2021
- First submitted
- 25 Feb 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Standardization of Ambulance Equipment on the Speed of Medical Procedures Provision
- ClinicalTrials.gov ID
- NCT04774900
- Acronym / sponsor ID
- ZZSHMP_002_2021
- Conditions
- Safety Issues
- Keywords
- quality and safety, emergency medical services, paramedics, equipment, standardisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- David PeranOther government
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Mar 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 aim of the research is to find out what effect the standardization of ambulance equipment has on the speed of performing specific medical procedures.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardised | – | 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 pneumothoraxThe procedures will be observed with standardized equipment placement. |
| Modified | – | 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 pneumothoraxThe procedures will be observed with modified equipment placement - placement according to older methodology or custom. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Paramedics of the Prague Emergency Medical Services - bachelor or higher professional education as paramedics.
Key inclusion criteria (3 listed)
- consent to participate
- times of all procedures recorded
- all procedures provided in a correct way - in meaning of quality of the procedure
Key exclusion criteria (2 listed)
- disagreement with participation
- not all procedures provided or not provided correctly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of oxygenAdministration of high-flow oxygen via face mask to a high fidelity mannequin. | Procedure or surgery | Modified, Standardised |
| Administration of drug in a nebulizerAdministration of bronchodilator via nebulizer mask to a high fidelity mannequin. | Procedure or surgery | Modified, Standardised |
| Securing intravenous lineSecuring an intravenous line at the forearm of high fidelity mannequin. | Procedure or surgery | Modified, Standardised |
| Administration of IV drugAdministration of bronchodilator via IV line to a high fidelity mannequin. | Procedure or surgery | Modified, Standardised |
| Needle decompression of tension pneumothoraxNeedle decompression of tension pneumothorax on a high fidelity mannequin. | Procedure or surgery | Modified, Standardised |
Primary outcome
Time
Time frame: Through study completion, an average of 6 months and/or until 100 cases will be collected.
Time from decision to execution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
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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.
David Peran, Dr. study chair
Prague EMS
Miroslav Tejkl, MS study director
Prague EMS
Roman Sýkora, Ph.D. principal investigator
EMS of Karlovy Vary Region
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 Safety Issues, run by David Peran at 1 site in Czechia.
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 3 inclusion and 2 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 18 Aug 2021. 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 Czechia. 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?
Contact David Peran, Dr. (00420 602 611 746, David.Peran@zzshmp.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: Through study completion, an average of 6 months and/or until 100 cases will be collected.). 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 18 Aug 2021.