Comparing Two Vagal Maneuvers for Paroxysmal Supraventricular Tachycardia (RVM-MVM)
23 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
142
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Düzce, Turquie (Türkiye), 81620
- Düzce University Faculty of Medicine Hospital, Department of Emergency Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Salih KARAKOYUN, MD, Department of Emergency Medicine, Düzce University Faculty of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2024
Achèvement primaire (Réel)
1 août 2025
Achèvement de l'étude (Réel)
1 août 2026
Dates d'inscription aux études
Première soumission
13 août 2026
Première soumission répondant aux critères de contrôle qualité
23 août 2026
Première publication (Réel)
25 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DU-RVM-MVM-PSVT-2023-04
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
Beginning 3 months after article publication and ending 2 years after article publication.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .