NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarmara University Pendik Training and Research Hospital

About this trial

Supraventricular tachycardia (SVT) is a common heart rhythm disorder seen in emergency departments, causing a rapid heartbeat (typically 150-250 beats per minute). The current best non-drug treatment, the modified Valsalva maneuver (mVM), successfully restores normal rhythm in about 43% of cases. When these maneuvers fail, intravenous adenosine is used, which, while effective, can cause brief but distressing side effects such as chest tightness, shortness of breath, and intense anxiety.

During the COVID-19 pandemic, some patients briefly fainted during nasal swab collection. This happens because inserting a swab into the back of the nasal cavity (nasopharynx) stimulates the trigeminal nerve, which then activates the vagus nerve and slows the heart - a phenomenon called the trigeminocardiac (or nasocardiac) reflex. One published case report described a patient whose SVT was terminated within 10 seconds using a nasal swab.

This study compares the nasal swab technique with the modified Valsalva maneuver in patients presenting to the emergency department with SVT. Patients are randomly assigned to one of two groups. The primary outcome is whether a normal heart rhythm is restored within 1 minute of the procedure. Patient comfort and satisfaction are also measured.

The study is conducted in two phases. The first (pilot) phase (30 patients per group) will assess whether the study can be successfully conducted and collect data to finalize the required sample size. The second (main) phase will use the pilot phase's actual data to determine the final number of participants needed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Electrocardiographically confirmed supraventricular tachycardia (SVT): narrow QRS complex (≤120 ms), regular rhythm, rapid ventricular rate, documented on 12-lead ECG or continuous cardiac monitoring

Systolic blood pressure ≥90 mmHg

Diastolic blood pressure ≥60 mmHg

Disqualifiers

Age younger than 18 years

Pregnancy (known or suspected)

Inability to confirm SVT diagnosis by ECG criteria

Delta wave or pre-excitation pattern on ECG (Wolff-Parkinson-White syndrome or asymptomatic pre-excitation) - due to risk of ventricular fibrillation with vagal maneuvers

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nasopharyngeal Swab Insertion

    Procedure/Surgery

    A standard nasopharyngeal swab (approximately 15 cm flexible nylon-tipped swab, sterile) is inserted through the right nostril (left if anatomically impeded), directed parallel to the nasal septum along the nasal floor (posteriorly, not superiorly), and advanced until mild resistance is felt at the nasopharyngeal vault. The swab is held in this position for 10 seconds with optional gentle rotation, then slowly withdrawn. The procedure is performed with the patient in a 45-degree semi-recumbent position under continuous cardiac monitoring (ECG, SpO2, NIBP). T=0 is defined as the moment the swab is fully withdrawn. The procedure is performed once; failure leads to rescue therapy (intravenous adenosine) without a second attempt.

  • Modified Valsalva Maneuver (REVERT Protocol)

    Procedure/Surgery

    The modified Valsalva maneuver is performed per the REVERT protocol. The patient, seated at 45 degrees, performs a forced expiration for 15 seconds into the barrel of a 10 mL syringe (aiming to push the plunger back, targeting an expiratory pressure of≥40 mmHg). Immediately upon completion, the patient is rapidly repositioned supine, and both legs are passively elevated to 45 degrees for 15 seconds, then returned to the semi-recumbent position. Total maneuver duration is approximately 30 seconds. T=0 is defined as the moment the patient returns to the semi-recumbent position. The procedure is performed once; failure leads to rescue therapy (intravenous adenosine) without a second attempt.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Nasal Swab GroupExperimental treatment 1 intervention
Group B: Modified Valsalva GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sinus Rhythm Conversion Rate at 1 Minute

Proportion of participants who convert to sinus rhythm within 1 minute of procedure completion (T=60 seconds), as assessed by continuous 12-lead ECG monitoring. T=0 is defined as the moment the intervention is completed (swab withdrawn / patient returned to semi-recumbent position after leg raise). Rhythm is independently verified by two investigators reviewing the ECG rhythm strip recording. Conversion is defined as a dichotomous outcome: yes (sinus rhythm confirmed at T=60 seconds) or no.

Time frame
1 minute after procedure completion

Secondary outcomes

1

Sinus Rhythm Conversion Rate at 5 Minutes

Proportion of participants who convert to sinus rhythm within 5 minutes of procedure completion, assessed by continuous ECG monitoring.

Time frame
5 minutes after procedure completion
2

Adverse Events Profile

Incidence and nature of adverse events including but not limited to epistaxis, vasovagal syncope, significant bradycardia (heart rate \<40 bpm), hypotension, and respiratory distress, documented on a structured adverse event checklist.

Time frame
During procedure and up to 30 minutes after procedure completion

Other outcomes

Sponsors and contacts

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