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Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia (Para-SVT)

Primary Purpose

Supraventricular Tachycardia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Paramedic
Standard care
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraventricular Tachycardia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Patients presenting with regular narrow complex tachycardia on 12 lead ECG

Exclusion Age < 16 years Already enrolled in the study or another research study Syncope or blackout Sinus tachycardia ECG evidence of myocardial infarction Broad Complex tachycardia A history of illicit drug use within the previous 24 hours A history of structural or ischaemic heart disease Inability or unwillingness to give consent Pregnancy Failure to obtain intravenous access Hypotension - defined as a systolic blood pressure of <100 systolic Contraindications to Adenosine injection Heart transplant patients Patients on dipyridamole Patients on regular asthma inhalers Obvious atrial flutter

Sites / Locations

  • Barts Health NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Accident and emergency

Paramedic

Arm Description

Patients randomised to A&E were treated as per standard care and given no information other than that pertaining to the study.

Treatment at the scene by a paramedic. Valsalva manoeuvre with subsequent administration of 6mg and 12mg of adenosine unless the supraventricular tachycardia terminated. Patients were taken to accident and emergency if the tachycardia did not terminate, restarted, or the patient had continuing symptoms, a persistently abnormal ECG (other than T wave inversion) or was heamodynamically unstable. Prior to discharge from the ambulance patients received an information pack and a referral letter for their GP to refer them to an arrhythmia clinic.

Outcomes

Primary Outcome Measures

The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up

Secondary Outcome Measures

Full Information

First Posted
August 12, 2014
Last Updated
August 12, 2014
Sponsor
Barts & The London NHS Trust
Collaborators
London Ambulance Service NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02216240
Brief Title
Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia
Acronym
Para-SVT
Official Title
Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
London Ambulance Service NHS Trust

4. Oversight

5. Study Description

Brief Summary
Supraventricular tachycardia (SVT) is a term describing any rhythm coming from the top half of the heart. Although atrial fibrillation is the commonest cardiac arrhythmia, regular SVT's are also common. The two commonest regular SVT's are atrioventricular (nodal) reentry tachycardias (AV(N)RT) and atrial flutter (AFL). Atrioventricular (nodal) reentry tachycardias (AV(N)RT) are common but benign forms of fast heart rhythm. Although AV(N)RT can cause unpleasant symptoms and are frightening it is not dangerous. If patients present with AV(N)RT the accepted and normal treatment for most is to have the fast heart rhythm stopped by either taking a deep breath and straining or by the use of drugs. Patients can then be discharged home and have further investigation and treatment as an outpatient. SVT can be frightening for the patient but is easy to diagnose and treat. There is high success rate post treatment for this benign condition. This is traditionally done in the local accident and emergency, although patients can sometimes be unnecessarily admitted to hospital overnight. We propose to investigate the safety and efficacy of training paramedics to treat safe forms of AV(N)RT at the scene and then giving the patient an information pack which includes a request for a GP referral to a heart rhythm specialist. Patients will be randomly allocated after consenting to take part in the study to either get paramedic or accident and emergency department treatment. We will compare these two approaches by telephone follow up of the patients. The costs of the different approaches will be compared by assessing the rate of appropriate investigation and the information given to patients and how they rated their experiences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Accident and emergency
Arm Type
Active Comparator
Arm Description
Patients randomised to A&E were treated as per standard care and given no information other than that pertaining to the study.
Arm Title
Paramedic
Arm Type
Experimental
Arm Description
Treatment at the scene by a paramedic. Valsalva manoeuvre with subsequent administration of 6mg and 12mg of adenosine unless the supraventricular tachycardia terminated. Patients were taken to accident and emergency if the tachycardia did not terminate, restarted, or the patient had continuing symptoms, a persistently abnormal ECG (other than T wave inversion) or was heamodynamically unstable. Prior to discharge from the ambulance patients received an information pack and a referral letter for their GP to refer them to an arrhythmia clinic.
Intervention Type
Other
Intervention Name(s)
Paramedic
Intervention Type
Other
Intervention Name(s)
Standard care
Primary Outcome Measure Information:
Title
The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Patients presenting with regular narrow complex tachycardia on 12 lead ECG Exclusion Age < 16 years Already enrolled in the study or another research study Syncope or blackout Sinus tachycardia ECG evidence of myocardial infarction Broad Complex tachycardia A history of illicit drug use within the previous 24 hours A history of structural or ischaemic heart disease Inability or unwillingness to give consent Pregnancy Failure to obtain intravenous access Hypotension - defined as a systolic blood pressure of <100 systolic Contraindications to Adenosine injection Heart transplant patients Patients on dipyridamole Patients on regular asthma inhalers Obvious atrial flutter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Baker, RN MSc
Phone
02034656763
Email
victoria.baker@bartshealth.nhs.uk
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Baker, RN MSc
Phone
02034656763
Email
victoria.baker@bartshealth.nhs.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
27613170
Citation
Honarbakhsh S, Baker V, Kirkby C, Patel K, Robinson G, Antoniou S, Richmond L, Ullah W, Hunter RJ, Finlay M, Earley MJ, Whitbread M, Schilling RJ. Safety and efficacy of paramedic treatment of regular supraventricular tachycardia: a randomised controlled trial. Heart. 2017 Sep;103(18):1413-1418. doi: 10.1136/heartjnl-2016-309968. Epub 2016 Sep 9.
Results Reference
derived

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Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia

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