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临床试验/NCT05022290
NCT05022290招募中不适用

Comparison of Double-syringe vs Single-syringe Technique of Adenosine Administration for Termination of Regular-narrow Complex Tachycardia: A Randomized, Controlled Trial

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Termination of supraventricular tachycardia (SVT)

研究概览

简要总结

Adenosine has been discovered since 1929 and used in the acute treatment of arrhythmias. It uses as a therapeutic diagnosis in patients with regular narrow QRS complex tachyarrhythmias. The conventional method of adenosine administration is the double syringe technique (DST). However, it consumes a lot of resources including two syringes, a stopcock, an extension tube, and needs 2 nurses to administer. An observational study found that a single syringe technique (adenosine diluted with normal saline up to 20 ml) was as effective as a double syringe technique. However, there is no randomized control trial for proving its efficacy.

详细描述

Supraventricular tachycardia (SVT) is the most common tachyarrhythmias in young adults, children, and infants. The most common type in adults is the atrioventricular nodal reentrant tachycardia (AVNRT) and the incidence is 35 per 10,000 person-years or 2.29 per 1000 persons.

The treatment approach of SVT is based on hemodynamical stability. The synchronized cardioversion is recommended for hemodynamically unstable patients, on the other hand, the vagal maneuvers and medications are considered for patients with stable hemodynamic.

To date, the 2019 ESC guideline for the management of supraventricular tachycardia stated that adenosine is still the first medication for acute therapy in patients with SVT if the vagal maneuver fails or is contraindicated. A systematic review in 2021 showed that adenosine is equally efficacious for treating SVT, but it is safer than intravenous calcium channel blockers due to a shorter half-life.

Few studies reported that the effectiveness of conventional vagal maneuvers, namely, carotid sinus massage in SVT termination was around 19 to 54% when properly done. The enhanced method of vagal maneuver or named the modified syringe technique was performed by blowing into a 10 mL syringe to move the plunger, the success conversion rate of SVT was a little better than the convention technique (43% vs 17%). Therefore, adenosine is still crucial in the acute therapy of SVT in an emergency setting.

Adenosine has been discovered since 1929 and used in the acute treatment of arrhythmias. It was used as a therapeutic diagnosis in patients with regular narrow QRS complex tachyarrhythmias and it is also helpful in treating some type of regular wide QRS complex tachyarrhythmias (differentiate between SVT with aberrancy/bundle branch block and ventricular tachycardia).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

There will be an opaque fabric shade that covered the participant's right upper arm during treatment that does not allow them to see the methods of drug administration.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-80 years old
  • EKG shows regular rhythm, narrow QRS complex tachyarrhythmias (QRS complex <0.12 msec, and rate >150 beats per minute; bpm)
  • Pulse can be palpated
  • The tachycardia is not terminated by a vagal maneuver.

排除标准

  • Acute asthmatic attack
  • Pregnant or tendency to be pregnant
  • Acute heart failure
  • Acute chest pain
  • Alteration of consciousness
  • Hypotension
  • Presenting of signs of hypoperfusion

结局指标

主要结局

Termination of supraventricular tachycardia (SVT)

时间窗: 1 minute after complete administration of adenosine intravenously

The outcome is achieved when doctor in charge determine that the supraventricular tachycardia is terminated by administration of adenosine with the EKG after treatment showing sinus rhythm.

次要结局

  • Total dose of adenosine used for termination of supraventricular tachycardia(10 minutes after diagnosis of supraventricular tachycardia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Praew Kotruchin

Associate professor

Khon Kaen University

研究点 (2)

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