- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02216240
Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia (Para-SVT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, EC1A 7BE
- Barts Health NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Accident and emergency
Patients randomised to A&E were treated as per standard care and given no information other than that pertaining to the study.
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|
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Experimental: Paramedic
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005795QM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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