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

Primary Purpose

Supraventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Agitated saline push
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Supraventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Regions Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Simulation arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to ultrasound visualization of agitated saline in the right heart
Time from IV push to ultrasound visualization of agitated saline in the right heart

Secondary Outcome Measures

Full Information

First Posted
August 7, 2019
Last Updated
June 28, 2023
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04051541
Brief Title
Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound
Official Title
Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a simulation study in which all participants receive a dose of agitated saline through an IV using three different administration methods.
Masking
None (Open Label)
Masking Description
The investigator performing the ultrasound and the person timing the simulation were both blind to the method used for each push. An unblended investigator performed the pushes but did not assess the outcomes.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simulation arm
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Agitated saline push
Intervention Description
Push of agitated saline to simulate adenosine used for supraventricular tachycardia
Primary Outcome Measure Information:
Title
Time to ultrasound visualization of agitated saline in the right heart
Description
Time from IV push to ultrasound visualization of agitated saline in the right heart
Time Frame
<5 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
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Citation
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Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound

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