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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06077799
Other study ID # 296-2023-OSS-AUSLBO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 14, 2023
Est. completion date June 2024

Study information

Verified date October 2023
Source Azienda Usl di Bologna
Contact Lorenzo Gamberini, MD
Phone 0039 340 3550540
Email lorenzo.gamberini@ausl.bologna.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective multicentre study on management of supraventricular tachycardia in prehospital setting.


Description:

Supraventricular tachycardia in prehospital setting may be managed with adenosine administration or with synchronised electrical cardioversion and there's no clear advantage between the two, even if international guidelines suggests to practice drug-first method.This study aims to evaluate any difference in outcomes and efficacy of the two methods and possible adverse effects of both.


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients accepting to participate - patients affected by supraventricular tachycardia that are managed prehospitally by the emergency medical service Exclusion Criteria: - not willing to participate, not able to give consent

Study Design


Locations

Country Name City State
Italy Azienda Unità Sanitaria Locale Bologna

Sponsors (1)

Lead Sponsor Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of adenosine versus electric cardioversion in obtaining successful cardioversion of PSVT absolute numbers and relative percentages of successful prehospital cardioversions obtained with the two techniques Prehospital EMS assistance time
Secondary diagnostic accuracy for supraventricular tachycardia of the emergency medical service personnel Sensitivity for PSVT of the EMS personnel Prehospital EMS assistance time
Secondary adverse events incidence of predefined serious adverse events (SAE) between the two groups Prehospital EMS assistance time
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