prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia

Tachycardia, Supraventricular Clinical Trial

— INFLICT  

Official title:

prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia - Gestione Preospedaliera Della Tachicardia Parossistica Sopraventricolare

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077799
• Other study ID #: 296-2023-OSS-AUSLBO
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular

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