Clincosm LogoSign in Get a demo

INFLICT: prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia

Sponsor
Azienda Usl di Bologna (Other)
Overall Status
Recruiting
CT.gov ID
NCT06077799
Collaborator
(none)
900
Enrollment
1
Location
11.6
Anticipated Duration (Months)
77.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia - Gestione Preospedaliera Della Tachicardia Parossistica Sopraventricolare
    Actual Study Start Date :
    Jun 14, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    supraventricular tachycardia treated with intra-venous adenosine

    supraventricular tachycardia treated with intra-venous adenosine
    supraventricular tachycardia treated with electrical synchronised cardioversion

    supraventricular tachycardia treated with electrical synchronised cardioversion

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of adenosine versus electric cardioversion in obtaining successful cardioversion of PSVT [Prehospital EMS assistance time]

      absolute numbers and relative percentages of successful prehospital cardioversions obtained with the two techniques

    Secondary Outcome Measures

    1. diagnostic accuracy for supraventricular tachycardia of the emergency medical service personnel [Prehospital EMS assistance time]

      Sensitivity for PSVT of the EMS personnel

    2. adverse events [Prehospital EMS assistance time]

      incidence of predefined serious adverse events (SAE) between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Unità Sanitaria Locale Bologna Italy 40100

    Sponsors and Collaborators

    • Azienda Usl di Bologna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Azienda Usl di Bologna
    ClinicalTrials.gov Identifier:
    NCT06077799
    Other Study ID Numbers:
    • 296-2023-OSS-AUSLBO
    First Posted:
    Oct 11, 2023
    Last Update Posted:
    Oct 11, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Azienda Usl di Bologna
    supraventricular tachycardia
    Additional relevant MeSH terms:
    Tachycardia
    Tachycardia, Supraventricular
    Tachycardia, Ventricular

    Study Results

    No Results Posted as of Oct 11, 2023