Paroxysmal Supraventricular Tachycardia (PSVT)
Conditions
Keywords
Paroxysmal supraventricular tachycardia, modified Valsalva maneuver, reverse vagal maneuver
Brief summary
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.
Interventions
PROCEDUREModified 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.
PROCEDUREReverse 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.
Sponsors
Salih Karakoyun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and treating clinicians were not masked because the two maneuvers were visibly different. Electrocardiograms used for outcome assessment were anonymized and coded, with allocation and maneuver information removed. An independent physician who was unaware of the assigned intervention reviewed the recordings. Uncertain recordings were adjudicated by a second masked physician.
Intervention model description
This was a single-center, two-arm, parallel-group randomized controlled superiority trial. Hemodynamically stable adults with electrocardiogram-confirmed paroxysmal supraventricular tachycardia were randomly assigned in a 1:1 ratio to either the reverse vagal maneuver or the modified Valsalva maneuver. An independent researcher generated a computer-based permuted-block randomization sequence with variable block sizes. Allocation was concealed in sequentially numbered, opaque, sealed envelopes. Participants received only their assigned maneuver, which could be repeated up to three times if sinus rhythm was not restored. No crossover to the alternative maneuver was planned before rescue treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG-Confirmed Conversion to Sinus Rhythm During the Assigned Maneuver Protocol | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assigned Maneuver Attempt at ECG-Confirmed Conversion to Sinus Rhythm | 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. |
| Number of Participants Receiving Rescue Medication During the Index Emergency Department Visit | 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. |
| Number of Participants Undergoing Electrical Cardioversion During the Index Emergency Department Visit | 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. |
| Number of Participants With Recurrent PSVT During Emergency Department Observation | 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. |
| Number of Participants in Each Emergency Department Disposition Category at the End of the Index 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. | 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. |
| Repeat Emergency Department Presentation for PSVT | Up to 1 year after randomization | Repeat emergency department presentation for PSVT during follow-up. |
| Catheter Ablation During Follow-up | Up to 1 year after randomization | Catheter ablation performed for PSVT after the index emergency department visit. |
| Participants Experiencing Any Prespecified Adverse Event | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORSalih KARAKOYUN, MD
Department of Emergency Medicine, Düzce University Faculty of Medicine
Outcome results
None listed