Modified Valsalva Maneuver: A Realist Evaluation

Supraventricular Tachycardia Clinical Trial

Official title:

Improving the Care Trajectory for Patients With Paroxysmal Supraventricular Tachycardia in the Emergency Department by Implementing the Modified Valsalva Maneuver: A Realist Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466227
• Other study ID #: Z-2022052
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: Hanne Gworek, MD
• Phone: +32474521990
• Email: hanne.gw[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiac arrhythmia, specifically paroxysmal supraventricular tachycardia (SVT), accounts for a substantial proportion of emergency medical services resources utilization. Restoring a normal sinus rhythm (reconversion) should be done quickly and effectively. Reconversion requires increasing the atrioventricular node's refractoriness, which can be achieved by vagal maneuvers, pharmacological agents, or electrical cardioversion.

The Valsalva Maneuver (VM) is a commonly used non-invasive reconversion method. It increases myocardial refractoriness by increasing intrathoracic pressure for a brief period, thus stimulating baroreceptor activity in the aortic arch and carotid bodies, resulting in increased parasympathetic (vagus nerve) tone. The effectiveness of conventional vagal maneuvers in terminating SVT, when correctly performed, shows a considerable variation ranging from 19.4% to 54.3%. To improve the effectiveness of the Valsalva Maneuver, the Modified Valsalva Maneuver (MVM) was introduced. While the standard VM is performed when the patient is in a sitting position (45°-90°), the modified VM involves having the patient sit up straight and perform a forced expiration for about 15 seconds, after which the patient is brought into a supine position with the legs raised (45°) for another 15 seconds. This modification should increase relaxation, phase venous return, and vagal stimulation. A recent meta-analysis demonstrated a significantly higher success rate for reconversion to sinus rhythm when using the MVM compared to the standard VM in patients with an SVT (Odds Ratio = 4.36; 95 percent c.i. 3.30 to 5.76; P < .001). More adverse events were reported in the MVM group, although this difference is not significant (Risk Ratio = 1.48; 95 percent c.i. 0.91 to 2.42; P = .11). The available evidence suggests that medication use was lower in the MVM group than in the standard VM group. However, medication use could not be generalized across the different studies. None of the included studies in this review showed a significant difference in length of stay in the emergency department (ED). Hence, the gain of implementing MVM is a higher rate of success with non-invasive reconversion methods. While the available evidence is highly suggestive of supporting the use of the MVM compared to the standard VM in the treatment of adult patients with SVT, implementation seems difficult.

Current evaluations, such as the 'gold-standard' randomised controlled trial (RCT) design, rarely adequately or even explicitly address the context-specific drivers behind implementation outcomes and their relationship to the underlying programme theory, making it difficult to interpret their findings in light of other programmes in different settings. As a result, few evaluation strategies are widely accepted as appropriate. The net benefit of interventions and understanding how variable outcomes are achieved remains empirically uncertain. Therefore, it is essential to develop comprehensive, rigorous, and practical methods to evaluate people-centred quality improvement programmes, inform the selection of effective and efficient interventions, and facilitate improvement and scaling-up. In evaluating such complex interventions, the Medical Research Council (MRC) argues for the importance of process evaluation in conjunction with outcome evaluation to account for variability in implementation. The MRC's process evaluation framework guides evaluators to understand the implementation processes (what is implemented and how), mechanisms of intervention (how the delivery of the intervention produces change) and contextual factors that affect implementation and outcomes.

Research question This study aimed to evaluate a quality improvement program to improve the non-invasive care for patients with paroxysmal supraventricular tachycardia in the emergency department.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• All adult patients that present to the emergency department

• Only true SVT will be included.

Exclusion Criteria:

• ECG more suggestive of atrial fibrillation or atrial flutter

• Age < 18 years or > 70 years

• Broad QRS, including known aberration

• Known aneurysm (aortic, intracranial or elsewhere)

• Known aortic stenosis

• Known glaucoma

• Hemodynamic instability requiring immediate electric cardioversion.

• Patients that experience an SVT in the hospital but are never admitted to the emergency department (e.g., patients in the cardiac care unit), as the MVM protocol will be only implemented in the prehospital setting and ED.

Related Conditions & MeSH terms

• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular

Intervention

Other:
• Implementation of Modified Valsalva maneuvre
Modified Valsalva maneuvre: Patient is attached to 12-lead ECG monitoring The patient sits in an upright position and performs forced expiration for 15 seconds by blowing on a 10 mL syringe Patient's legs are elevated (45°) for 15 seconds Afterwards, the patient is placed back in an upright position If not efficient, this maneuver can be repeated up to two times

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Was Modified Valsalva maneuver used in this patient?	Yes/No. Was the patient's supraventricular tachycardie treated with Modified Valsalva or did they use a different treatment?	Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary	Was there a need for the use of medication or was the Modified Valsalva maneuver sufficient?		Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary	Length of stay in the ED	How long did the patient stayed in the emergency department?	Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary	Adverse events	Where there any adverse events correlated to the treatment used?	Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary	Hospital admission	Was there a need to admit the patient to the hospital?	Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary	Patient experience	Is it the first time you experienced this rhythm disturbance? To your knowledge, did they treat you by medication, or did they have you do a special maneuver?; If they have made you do a special maneuver: Can you describe what maneuver they made you do?; How many times did you do this maneuver?; Was it successful?; How did you experience this treatment?; If they used medication for your rhythm disturbance: How many times did they give you this medication?; How did you experience this treatment? If you were treated both by a maneuver and the medication, how did you experience one versus the other?	Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary	Staff experience	Do you know the recently implemented protocol of modified Valsalva maneuver in the treatment of an SVT? Did you use a non-pharmacological maneuver for termination of the SVT?; Yes/No; If you did not use a non-pharmacological maneuver, explain why.; If you did use a non-pharmacological maneuver: What maneuver did you use?; Can you describe it step by step? How many times did you apply this maneuver before it was successful or before you stopped trying it?; Was it successful?; If it was not successful, what was your next step? Did you use medication for the SVT?; Yes/No; What medication did you use?; How many times did you have to give this medication?; Was it successful? According to your experience, how do you rate the crowding of the ED on a Likert scale of 0-10?	Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary	Efficiency	Was the supraventricular tachycardia terminated after the used treatment (modified valsalva, valsalva, medication)?	Moment of treatment, no follow up. Up to 1 year since start of the study.