Comparing Two Vagal Maneuvers for Paroxysmal Supraventricular Tachycardia (RVM-MVM)
23 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
142
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Düzce, Turquia (Türkiye), 81620
- Düzce University Faculty of Medicine Hospital, Department of Emergency Medicine
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Salih KARAKOYUN, MD, Department of Emergency Medicine, Düzce University Faculty of Medicine
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de março de 2024
Conclusão Primária (Real)
1 de agosto de 2025
Conclusão do estudo (Real)
1 de agosto de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
13 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de agosto de 2026
Primeira postagem (Real)
25 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DU-RVM-MVM-PSVT-2023-04
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Beginning 3 months after article publication and ending 2 years after article publication.
Critérios de acesso de compartilhamento 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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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