Comparing Two Vagal Maneuvers for Paroxysmal Supraventricular Tachycardia (RVM-MVM)
23 августа 2026 г. обновлено: Salih Karakoyun
Reverse Vagal Maneuver Versus Modified Valsalva Maneuver for Paroxysmal Supraventricular Tachycardia: A Randomized Controlled Trial
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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
142
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Düzce, Турция (Туркие), 81620
- Düzce University Faculty of Medicine Hospital, Department of Emergency Medicine
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- Systolic blood pressure below 90 mm Hg
- Shock
- 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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Reverse Vagal Maneuver
Reverse vagal maneuver.
Seated participants exhaled normally without force, occluded the nose and mouth, and attempted forceful inspiration against the closed airway for 15 seconds.
The supervising clinician verified airway occlusion and completion of the prescribed sequence and duration .
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Participants performed the maneuver while seated.
After exhaling normally without force, they occluded the nose and mouth and attempted forceful inspiration against the closed airway for 15 seconds.
The supervising clinician verified airway occlusion and completion of the prescribed sequence and duration.
The maneuver could be repeated up to three times if sinus rhythm was not restored.
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Активный компаратор: Modified Valsalva Maneuver
Modified Valsalva maneuver.
Participants were positioned semirecumbent with the stretcher head elevated approximately 45° and instructed to blow into a 10-mL syringe for 15 seconds with sufficient force to move the plunger, aiming to generate approximately 40 mm Hg of expiratory pressure.
Pressure was not measured by manometer.
Immediately afterward, participants were placed supine and their legs were elevated to approximately 45°, without knee flexion, for 15 seconds.
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Participants were positioned semirecumbent with the stretcher head elevated to approximately 45° and instructed to blow into a 10-mL syringe for 15 seconds with sufficient force to move the plunger, aiming to generate approximately 40 mm Hg of expiratory pressure.
Pressure was not measured using a manometer.
Immediately afterward, participants were placed supine, and their legs were elevated to approximately 45°, without knee flexion, for 15 seconds.
The maneuver could be repeated up to three times if sinus rhythm was not restored.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol
Временное ограничение: 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
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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.
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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
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm
Временное ограничение: 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
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Conversion was categorized as occurring after the first, second, or third assigned maneuver attempt, or as no conversion, based on ECG assessment 45 seconds after each attempt.
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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
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Number of Participants Receiving Rescue Medication During the Index Emergency Department Visit
Временное ограничение: From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours)
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Number of participants who received pharmacologic rescue treatment for persistent PSVT after failure or early discontinuation of the assigned maneuver protocol, or for recurrent PSVT after ECG-confirmed initial conversion during emergency department observation.
Each participant was counted once, regardless of the number or type of rescue medications administered.
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From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours)
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Number of Participants Undergoing Electrical Cardioversion During the Index Emergency Department Visit
Временное ограничение: From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours).
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Number of participants who underwent electrical cardioversion for persistent or recurrent PSVT during the index emergency department visit.
Electrical cardioversion could be performed after failure or early discontinuation of the assigned maneuver protocol, or earlier if clinically indicated because of hemodynamic instability, clinical deterioration, intolerable symptoms, or concern that another assigned maneuver attempt was unsafe.
Each participant was counted once, regardless of the number of cardioversion attempts performed.
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From randomization until emergency department discharge or transfer to inpatient care, whichever occurred first, during the index visit (estimated assessment period: 4 hours).
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Number of Participants With Recurrent PSVT During Emergency Department Observation
Временное ограничение: 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.
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Number of randomized participants who experienced recurrence of PSVT after an initially successful ECG-confirmed conversion to sinus rhythm and before emergency department discharge or transfer to inpatient care during the index visit.
Each participant was counted once, regardless of the number of recurrent PSVT episodes.
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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.
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Number of Participants in Each Emergency Department Disposition Category at the End of the Index Visit
Временное ограничение: 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.
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Number of participants in each of three mutually exclusive emergency department disposition categories: discharge from the emergency department, admission to a hospital ward, or admission to an intensive care unit.
Each participant was classified in one disposition category at the end of the index emergency department visit.
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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.
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Repeat Emergency Department Presentation for PSVT
Временное ограничение: Up to 1 year after randomization
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Repeat emergency department presentation for PSVT during follow-up.
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Up to 1 year after randomization
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Catheter Ablation During Follow-up
Временное ограничение: Up to 1 year after randomization
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Catheter ablation performed for PSVT after the index emergency department visit.
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Up to 1 year after randomization
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Participants Experiencing Any Prespecified Adverse Event
Временное ограничение: From initiation of the first assigned maneuver attempt through completion of emergency department observation, an average of 4 hours after randomization
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This composite binary outcome indicated whether a participant experienced at least one prespecified adverse event during the assigned maneuver protocol or subsequent emergency department observation.
Prespecified events included dizziness, nausea, dyspnea, presyncope, syncope, chest pain, hypotension, worsening arrhythmia, and other clinically important maneuver-related events.
Each participant was counted once, regardless of the number or type of events experienced, and the outcome was reported as the number of participants with at least one event.
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From initiation of the first assigned maneuver attempt through completion of emergency department observation, an average of 4 hours after randomization
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Salih KARAKOYUN, MD, Department of Emergency Medicine, Düzce University Faculty of Medicine
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Corbacioglu SK, Akinci E, Cevik Y, Aytar H, Oncul MV, Akkan S, Uzunosmanoglu H. Comparing the success rates of standard and modified Valsalva maneuvers to terminate PSVT: A randomized controlled trial. Am J Emerg Med. 2017 Nov;35(11):1662-1665. doi: 10.1016/j.ajem.2017.05.034. Epub 2017 May 22.
- Appelboam A, Reuben A, Mann C, Gagg J, Ewings P, Barton A, Lobban T, Dayer M, Vickery J, Benger J; REVERT trial collaborators. Postural modification to the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial. Lancet. 2015 Oct 31;386(10005):1747-53. doi: 10.1016/S0140-6736(15)61485-4. Epub 2015 Aug 24.
- Gaudart P, Cazes N, Simon K, Larger D, Deharo JC. The reverse vagal manoeuvre: A new tool for treatment of supraventricular tachycardia? Am J Emerg Med. 2021 Mar;41:66-69. doi: 10.1016/j.ajem.2020.12.061. Epub 2020 Dec 26.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 марта 2024 г.
Первичное завершение (Действительный)
1 августа 2025 г.
Завершение исследования (Действительный)
1 августа 2026 г.
Даты регистрации исследования
Первый отправленный
13 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
23 августа 2026 г.
Первый опубликованный (Действительный)
25 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
25 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
23 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- DU-RVM-MVM-PSVT-2023-04
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
De-identified individual participant data supporting the findings of this study will be available from the corresponding author upon reasonable request, subject to applicable ethical and institutional data-sharing requirements.
Сроки обмена IPD
Beginning 3 months after article publication and ending 2 years after article publication.
Критерии совместного доступа к IPD
Qualified researchers who submit a methodologically sound research proposal may request access to the de-identified individual participant data underlying the reported results and the study protocol.
Requests should be directed to the corresponding author at salihkarakoyun@duzce.edu.tr.
Access will be granted for analyses specified in an approved proposal, subject to applicable ethical and institutional data-sharing requirements.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .