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Comparing Two Vagal Maneuvers for Paroxysmal Supraventricular Tachycardia (RVM-MVM)

23. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

142

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
      • Düzce, Türkei (türkiye), 81620
        • Düzce University Faculty of Medicine Hospital, Department of Emergency Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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 .
Verfahren: Reverse Vagal Maneuver
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.
Aktiver Komparator: 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.
Verfahren: Modified Valsalva Maneuver
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol
Zeitfenster: 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.
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm
Zeitfenster: 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
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.
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
Zeitfenster: 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 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.
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
Zeitfenster: 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 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.
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
Zeitfenster: 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 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.
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
Zeitfenster: 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.
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.
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
Zeitfenster: Up to 1 year after randomization
Repeat emergency department presentation for PSVT during follow-up.
Up to 1 year after randomization
Catheter Ablation During Follow-up
Zeitfenster: Up to 1 year after randomization
Catheter ablation performed for PSVT after the index emergency department visit.
Up to 1 year after randomization
Participants Experiencing Any Prespecified Adverse Event
Zeitfenster: From initiation of the first assigned maneuver attempt through completion of emergency department observation, an average of 4 hours after randomization
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.
From initiation of the first assigned maneuver attempt through completion of emergency department observation, an average of 4 hours after randomization

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Salih Karakoyun

Ermittler

  • Hauptermittler: Salih KARAKOYUN, MD, Department of Emergency Medicine, Düzce University Faculty of Medicine

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2024

Primärer Abschluss (Tatsächlich)

1. August 2025

Studienabschluss (Tatsächlich)

1. August 2026

Studienanmeldedaten

Zuerst eingereicht

13. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. August 2026

Zuerst gepostet (Tatsächlich)

25. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DU-RVM-MVM-PSVT-2023-04

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

Beginning 3 months after article publication and ending 2 years after article publication.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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