Modified Valsalva Maneuver: A Realist Evaluation
NCT05466227 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-09-01
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
Interventions
- 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
Sponsors & Collaborators
-
Ziekenhuis Oost-Limburg
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-01
- Primary Completion
- 2023-12-30
- Completion
- 2024-06-30
Countries
- Belgium
Study Locations
More Related Trials
-
Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias
NCT07026695 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
NCT03453645 ·Status: UNKNOWN
-
Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department
NCT04005482 ·Status: UNKNOWN
-
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population
NCT02772354 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Venous Ethanol for Ventricular Tachycardia
NCT05511246 ·Status: RECRUITING ·Phase: PHASE2
-
Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
NCT02248753 ·Status: COMPLETED ·Phase: NA
-
Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study
NCT07148934 ·Status: NOT_YET_RECRUITING
-
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
NCT05148923 ·Status: COMPLETED ·Phase: NA
-
BTE and Pulsed Waveforms for Cardioversion of Atrial Fibrillation - Escalation Strategy and Manual Pressure
NCT05316753 ·Status: UNKNOWN ·Phase: NA
-
ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
NCT02301819 ·Status: COMPLETED ·Phase: NA
-
Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)
NCT03412240 ·Status: UNKNOWN ·Phase: NA
-
To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients
NCT01665755 ·Status: COMPLETED ·Phase: NA
-
Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
NCT02153437 ·Status: TERMINATED ·Phase: PHASE1
-
Differentiate AVNRT from Orthodromic AVRT
NCT06671145 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Shortening Duration of Antiarrhythmic Medication for SVT in Infants
NCT04837261 ·Status: COMPLETED
-
Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias
NCT01013714 ·Status: RECRUITING ·Phase: PHASE3
-
"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin
NCT06360003 ·Status: COMPLETED ·Phase: NA
-
Atrioventricular Nodal Reentrant Tachycardia Ablation With Irrigated Catheter and Three-dimensional Electroanatomic Mapping
NCT05109273 ·Status: ACTIVE_NOT_RECRUITING
-
A Real-world Study of Cardiac Ablation for PSVT Using ST Catheter
NCT04923815 ·Status: COMPLETED
-
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation
NCT05377216 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block
NCT05722379 ·Status: UNKNOWN
-
Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound
NCT04051541 ·Status: COMPLETED ·Phase: NA
-
Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
NCT06697145 ·Status: COMPLETED ·Phase: NA
-
Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
NCT05572034 ·Status: UNKNOWN ·Phase: NA
-
Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy
NCT06492499 ·Status: COMPLETED