Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound

June 28, 2023 updated by: HealthPartners Institute
Supraventricular tachycardia (SVT) is an abnormally fast heart rhythm arising from improper electrical activity in the upper part of the heart. SVT is commonly treated with adenosine using three different IV administration techniques. However, it is not well known which of these three techniques is the quickest or most likely to reach the heart in order to stop SVT. This study will simulate each of those techniques in an investigator-blinded procedure. Intravenous agitated saline, used as a surrogate for a dose of adenosine, will be administered to healthy volunteers using all three techniques and monitored using bedside ultrasound to observe their efficacy and speed in reaching the right side of the heart.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteers aged 18 years and older
  • Able to understand and provide signed consent for the study
  • Must be healthy; not being actively treated for any condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being, as evaluated by study investigator

Exclusion Criteria:

  • Non-English speaker
  • Those with contraindications to peripheral IV placement, such as infection or other contraindication noted from evaluation by study investigator
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Simulation arm
All patients were entered into the Simulation arm and received 3 pushes of agitated saline via 3 different methods of delivery. All patients received all methods. The order of the methods for each patient was randomized.
Push of agitated saline to simulate adenosine used for supraventricular tachycardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to ultrasound visualization of agitated saline in the right heart
Time Frame: <5 seconds
Time from IV push to ultrasound visualization of agitated saline in the right heart
<5 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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