Standardization of Ambulance Equipment
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04774900 |
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Recruitment Status :
Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : August 18, 2021
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| 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 |
| 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 |
|---|---|
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Standardised
The procedures will be observed with standardized equipment placement.
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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. |
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Modified
The procedures will be observed with modified equipment placement - placement according to older methodology or custom.
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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. |
- 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 |
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
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
| 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 |
| Czechia | |
| Prague Emergency Medical Services | |
| Praha, Czechia, 10100 | |
| 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 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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quality and safety emergency medical services paramedics equipment standardisation |

