Reverse Vagal Maneuver Versus Modified Valsalva Maneuver for Paroxysmal Supraventricular Tachycardia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol
研究概览
简要总结
The goal of this clinical trial is to compare two physical techniques for treating paroxysmal supraventricular tachycardia in adults. This condition causes a fast, regular heartbeat that starts and stops suddenly. Participants must be medically stable and have the condition confirmed by an electrocardiogram (ECG).
The main question is:
Does the reverse vagal maneuver restore normal heart rhythm more often than the modified Valsalva maneuver before rescue treatment is needed?
Researchers randomly assign participants to one of the two maneuvers.
Participants assigned to the modified Valsalva maneuver sit in a partly upright position. They blow into a 10-mL syringe for 15 seconds with enough force to move the plunger. They then lie flat while their legs are raised for 15 seconds.
Participants assigned to the reverse vagal maneuver sit upright and breathe out normally. They then close their nose and mouth and try to breathe in forcefully for 15 seconds.
All participants have an ECG before the maneuver and continuous heart rhythm monitoring. If normal rhythm is not restored, the assigned maneuver may be repeated up to three times. An ECG is recorded 45 seconds after each attempt. Participants receive standard rescue treatment if the assigned maneuver does not restore normal rhythm or if continuing becomes unsafe.
Researchers also record first-attempt success, rescue medication, electrical cardioversion, return of the fast heartbeat, hospital disposition, unwanted effects, repeat emergency department visits, and catheter ablation during one year of follow-up.
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 (Outcomes Assessor)
盲法说明
Participants and treating clinicians were not masked because the two maneuvers were visibly different. Electrocardiograms used for outcome assessment were anonymized and coded, with allocation and maneuver information removed. An independent physician who was unaware of the assigned intervention reviewed the recordings. Uncertain recordings were adjudicated by a second masked physician.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Presentation to the emergency department with symptoms consistent with paroxysmal supraventricular tachycardia (PSVT)
- •Electrocardiogram-confirmed PSVT, defined as a regular narrow-complex tachycardia with a heart rate of 135 to 250 beats per minute and no clearly visible P waves
- •Hemodynamically stable at enrollment, as determined by the treating emergency physician
- •No acute antiarrhythmic medication received for the index episode before enrollment
- •No electrical therapy received for the index episode before enrollment
排除标准
- •Systolic blood pressure below 90 mm Hg
- •Evidence of hypoperfusion
- •Altered mental status attributable to tachycardia
- •Ischemic chest discomfort attributable to tachycardia
- •Syncope attributable to tachycardia
- •Acute heart failure attributable to tachycardia
- •Pulmonary edema attributable to tachycardia
- •Need for immediate cardioversion
- •Need for another urgent treatment
- •Inability to perform a vagal maneuver
- •Pregnancy
- •Body weight greater than 130 kg
- •Comorbidity making performance of a vagal maneuver unsafe
- •Previous operation making performance of a vagal maneuver unsafe
- •Prior familiarity with either study maneuver together with the ability to self-perform it
- •Reported acute use of a nonprescribed drug expected to affect heart rate or rhythm
- •Reported acute use of a stimulant expected to affect heart rate or rhythm
- •Reported acute exposure to another substance expected to affect heart rate or rhythm
- •Reported recent consumption of a food expected to affect heart rate or rhythm
- •Inability to provide informed consent
- •Spontaneous conversion to sinus rhythm before the study intervention
结局指标
主要结局
ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol
时间窗: At 45 seconds after the final performed assigned maneuver attempt, upon completion or early discontinuation of the protocol (maximum of 3 attempts) and before initiation of rescue therapy
The primary outcome was ECG-confirmed conversion from PSVT to sinus rhythm following any of up to three permitted attempts of the assigned vagal maneuver and before initiation of rescue medication or electrical cardioversion. Conversion was determined using the standardized ECG assessment performed 45 seconds after completion of each attempt. Participants who remained in PSVT after completion or early discontinuation of the assigned maneuver protocol were classified as non-converters.
次要结局
- Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm(At 45 seconds after each assigned maneuver attempt (attempts 1, 2, and 3), through completion of the assigned maneuver protocol and before initiation of rescue therapy)
- Number of Participants Receiving Rescue Medication During the Index Emergency Department Visit(From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours))
- Number of Participants Undergoing Electrical Cardioversion During the Index Emergency Department Visit(From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours).)
- Number of Participants With Recurrent PSVT During Emergency Department Observation(From the initial ECG-confirmed conversion to sinus rhythm until emergency department discharge or transfer to inpatient care, whichever occurred first, assessed over an estimated period of 4 hours during the index visit.)
- Number of Participants in Each Emergency Department Disposition Category at the End of the Index Visit(At the end of the index emergency department visit, defined as emergency department discharge or transfer to a hospital ward or intensive care unit, assessed approximately 4 hours after randomization.)
- Repeat Emergency Department Presentation for PSVT(Up to 1 year after randomization)
- Catheter Ablation During Follow-up(Up to 1 year after randomization)
- Participants Experiencing Any Prespecified Adverse Event(From initiation of the first assigned maneuver attempt through completion of emergency department observation, an average of 4 hours after randomization)
研究者
Salih Karakoyun
Assistant Professor of Emergency Medicine, Faculty of Medicine
Duzce University