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

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Supraventricular Tachycardia (PSVT)
• Intervention / Treatment: Procedure: Reverse Vagal Maneuver; Procedure: Modified Valsalva Maneuver

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Düzce, Turkey (Türkiye), 81620
    • Düzce University Faculty of Medicine Hospital, Department of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 .	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm	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	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	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	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	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	Repeat emergency department presentation for PSVT during follow-up.	Up to 1 year after randomization
Catheter Ablation During Follow-up	Catheter ablation performed for PSVT after the index emergency department visit.	Up to 1 year after randomization
Participants Experiencing Any Prespecified Adverse Event	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

Collaborators and Investigators

• Sponsor: Salih Karakoyun
• Investigators: Principal Investigator: Salih KARAKOYUN, MD, Department of Emergency Medicine, Düzce University Faculty of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2026

Study Registration Dates

• First Submitted: August 13, 2026
• First Submitted That Met QC Criteria: August 23, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 23, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Paroxysmal supraventricular tachycardia; modified Valsalva maneuver; reverse vagal maneuver
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular
• Other Study ID Numbers: DU-RVM-MVM-PSVT-2023-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Time Frame: Beginning 3 months after article publication and ending 2 years after article publication.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No