Modified Valsalva Maneuver: A Realist Evaluation

NCT ID: NCT05466227

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-06-30

Brief 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.

Conditions

Supraventricular Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implementing Modified Valsalva

Implementing Modified Valsalva

Group Type: EXPERIMENTAL

Implementation of Modified Valsalva maneuvre

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Pieter Jan Van Asbroeck

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status: NOT_YET_RECRUITING

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Hanne Gworek, MD

Role: CONTACT

hanne.gw@hotmail.com

+32474521990

Facility Contacts

Pieter Jan Van Asbroeck, MD

Role: primary

pjvanasbroeck@gmail.com

+32497139013

Hanne Gworek, MD

Role: backup

hanne.gw@hotmail.com

+32474521990

Ziekenhuis Oost-Limburg

Role: primary

Other Identifiers

Z-2022052

Identifier Type: -

Identifier Source: org_study_id