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Trial record 61 of 1152 for:    adenosine

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

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ClinicalTrials.gov Identifier: NCT04051541
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

Tracking Information
First Submitted Date  ICMJE August 7, 2019
First Posted Date  ICMJE August 9, 2019
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE May 6, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound
Official Title  ICMJE Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Other
Condition  ICMJE Supraventricular Tachycardia
Intervention  ICMJE Other: Agitated saline push
Push of agitated saline to simulate adenosine used for supraventricular tachycardia
Study Arms  ICMJE 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.
Intervention: Other: Agitated saline push
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2019)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 28, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04051541
Other Study ID Numbers  ICMJE A18-400
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HealthPartners Institute
Study Sponsor  ICMJE HealthPartners Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account HealthPartners Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP