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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04051541
Other study ID # A18-400
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 6, 2019
Est. completion date June 28, 2019

Study information

Verified date August 2019
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 28, 2019
Est. primary completion date June 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Agitated saline push
Push of agitated saline to simulate adenosine used for supraventricular tachycardia

Locations

Country Name City State
United States Regions Hospital Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

References & Publications (15)

Alabed S, Sabouni A, Providencia R, Atallah E, Qintar M, Chico TJ. Adenosine versus intravenous calcium channel antagonists for supraventricular tachycardia. Cochrane Database Syst Rev. 2017 Oct 12;10(10):CD005154. doi: 10.1002/14651858.CD005154.pub4. — View Citation

Brubaker S, Long B, Koyfman A. Alternative Treatment Options for Atrioventricular-Nodal-Reentry Tachycardia: An Emergency Medicine Review. J Emerg Med. 2018 Feb;54(2):198-206. doi: 10.1016/j.jemermed.2017.10.003. Epub 2017 Nov 26. — View Citation

Duran-Gehring PE, Guirgis FW, McKee KC, Goggans S, Tran H, Kalynych CJ, Wears RL. The bubble study: ultrasound confirmation of central venous catheter placement. Am J Emerg Med. 2015 Mar;33(3):315-9. doi: 10.1016/j.ajem.2014.10.010. Epub 2014 Oct 13. — View Citation

Gekle R, Dubensky L, Haddad S, Bramante R, Cirilli A, Catlin T, Patel G, D'Amore J, Slesinger TL, Raio C, Modayil V, Nelson M. Saline Flush Test: Can Bedside Sonography Replace Conventional Radiography for Confirmation of Above-the-Diaphragm Central Venous Catheter Placement? J Ultrasound Med. 2015 Jul;34(7):1295-9. doi: 10.7863/ultra.34.7.1295. — View Citation

Green AP, Giattina KH. Adenosine administration for neonatal SVT. Neonatal Netw. 1993 Aug;12(5):15-8. — View Citation

Ketkar VA, Kolling WM, Nardviriyakul N, VanDer Kamp K, Wurster DE. Stability of undiluted and diluted adenosine at three temperatures in syringes and bags. Am J Health Syst Pharm. 1998 Mar 1;55(5):466-70. doi: 10.1093/ajhp/55.5.466. — View Citation

Kleinman ME, Chameides L, Schexnayder SM, Samson RA, Hazinski MF, Atkins DL, Berg MD, de Caen AR, Fink EL, Freid EB, Hickey RW, Marino BS, Nadkarni VM, Proctor LT, Qureshi FA, Sartorelli K, Topjian A, van der Jagt EW, Zaritsky AL. Part 14: pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S876-908. doi: 10.1161/CIRCULATIONAHA.110.971101. No abstract available. — View Citation

Losek JD, Endom E, Dietrich A, Stewart G, Zempsky W, Smith K. Adenosine and pediatric supraventricular tachycardia in the emergency department: multicenter study and review. Ann Emerg Med. 1999 Feb;33(2):185-91. doi: 10.1016/s0196-0644(99)70392-6. — View Citation

Madsen CD, Pointer JE, Lynch TG. A comparison of adenosine and verapamil for the treatment of supraventricular tachycardia in the prehospital setting. Ann Emerg Med. 1995 May;25(5):649-55. doi: 10.1016/s0196-0644(95)70179-6. — View Citation

Murman DH, McDonald AJ, Pelletier AJ, Camargo CA Jr. U.S. emergency department visits for supraventricular tachycardia, 1993-2003. Acad Emerg Med. 2007 Jun;14(6):578-81. doi: 10.1197/j.aem.2007.01.013. Epub 2007 Apr 20. — View Citation

Neumar RW, Otto CW, Link MS, Kronick SL, Shuster M, Callaway CW, Kudenchuk PJ, Ornato JP, McNally B, Silvers SM, Passman RS, White RD, Hess EP, Tang W, Davis D, Sinz E, Morrison LJ. Part 8: adult advanced cardiovascular life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S729-67. doi: 10.1161/CIRCULATIONAHA.110.970988. Erratum In: Circulation. 2011 Feb 15;123(6):e236. Circulation. 2013 Dec 24;128(25):e480. — View Citation

Ng GA, Martin W, Rankin AC. Imaging of adenosine bolus transit following intravenous administration: insights into antiarrhythmic efficacy. Heart. 1999 Aug;82(2):163-9. doi: 10.1136/hrt.82.2.163. — View Citation

Weberding NT, Saladino RA, Minnigh MB, Oberly PJ, Tudorascu DL, Poloyac SM, Manole MD. Adenosine Administration With a Stopcock Technique Delivers Lower-Than-Intended Drug Doses. Ann Emerg Med. 2018 Feb;71(2):220-224. doi: 10.1016/j.annemergmed.2017.09.002. Epub 2017 Oct 28. — View Citation

Weekes AJ, Johnson DA, Keller SM, Efune B, Carey C, Rozario NL, Norton HJ. Central vascular catheter placement evaluation using saline flush and bedside echocardiography. Acad Emerg Med. 2014 Jan;21(1):65-72. doi: 10.1111/acem.12283. — View Citation

Wen M, Stock K, Heemann U, Aussieker M, Kuchle C. Agitated saline bubble-enhanced transthoracic echocardiography: a novel method to visualize the position of central venous catheter. Crit Care Med. 2014 Mar;42(3):e231-3. doi: 10.1097/CCM.0000000000000130. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 <5 seconds
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