Supraventricular TachycardiaNCT05466227
Modified Valsalva Maneuver: A Realist Evaluation
A study testing Implementation of Modified Valsalva maneuvre in people with Supraventricular Tachycardia, run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Implementation of Modified Valsalva maneuvre
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients that present to the emergency department
- Only true SVT will be included.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Pieter Jan Van Asbroeck, MD, +32497139013, pjvanasbroeck@gmail.com
Hanne Gworek, MD, +32474521990, hanne.gw@hotmail.com
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Ziekenhuis Oost-Limburg
About this study
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
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.
Read more
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
- Being tested
- Implementation of Modified Valsalva maneuvre
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Modified Valsalva maneuvreOther
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
| Study group | Role | What they receive |
|---|---|---|
| Implementing Modified Valsalva | Experimental | Implementing Modified Valsalva Receives: Other: Implementation of Modified Valsalva maneuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
Secondary outcomes (7)
Was there a need for the use of medication or was the Modified Valsalva maneuver sufficient?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
Length of stay in the ED
How long did the patient stayed in the emergency department?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
Adverse events
Where there any adverse events correlated to the treatment used?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
Hospital admission
Was there a need to admit the patient to the hospital?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
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?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
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?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
Efficiency
Was the supraventricular tachycardia terminated after the used treatment (modified valsalva, valsalva, medication)?
Measured: Moment of treatment, no follow up. Up to 1 year since start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jan 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a mixed-methods study that uses realist evaluation as the overall conceptual framework to examine a quality improvement program to improve the care for patients with paroxysmal supraventricular tachycardia in the emergency department. A realist evaluation is methods-neutral, and the use of a mixed-methods approach employing a case note review, interviews, and focus groups with patients and staff will generate and analyse both qualitative and quantitative data to achieve the goal of the evaluation. Analysis of qualitative and quantitative data will be carried out using a convergent mixed-methods approach to ensure continuous triangulation of multiple data, which will provide a greater understanding of the findings in relation to policy and practice. Broadly, the evaluation could also be considered a process and outcome evaluation.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter Jan Van Asbroeck, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466227
- Sponsor's protocol ID
- Z-2022052
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05466227
- Acronym / sponsor ID
- Z-2022052
- Conditions
- Supraventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a mixed-methods study that uses realist evaluation as the overall conceptual framework to examine a quality improvement program to improve the care for patients with paroxysmal supraventricular tachycardia in the emergency department. A realist evaluation is methods-neutral, and the use of a mixed-methods approach employing a case note review, interviews, and focus groups with patients and staff will generate and analyse both qualitative and quantitative data to achieve the goal of the evaluation. Analysis of qualitative and quantitative data will be carried out using a convergent mixed-methods approach to ensure continuous triangulation of multiple data, which will provide a greater understanding of the findings in relation to policy and practice. Broadly, the evaluation could also be considered a process and outcome evaluation.
| Arm | Type | Receives |
|---|---|---|
| Implementing Modified Valsalva | Experimental | Other: Implementation of Modified Valsalva maneuvreImplementing Modified Valsalva |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients that present to the emergency department
- Only true SVT will be included.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of Modified Valsalva maneuvreModified 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 | Other | Implementing Modified Valsalva |
Primary outcome
Was Modified Valsalva maneuver used in this patient?
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Yes/No. Was the patient's supraventricular tachycardie treated with Modified Valsalva or did they use a different treatment?
7 secondary outcomes
Was there a need for the use of medication or was the Modified Valsalva maneuver sufficient?
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Length of stay in the ED
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Adverse events
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Hospital admission
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Patient experience
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Staff experience
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Efficiency
Time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Supraventricular Tachycardia
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Active, not recruitingPhase 1/2
Treatment of Orthostatic Intolerance
Tachycardia, Chronic Orthostatic Intolerance
Not yet recruitingObservational study
Cardiac Arrhythmias in Pediatric Emergency Department
Arrhythmias, Cardiac, Tachycardia, Supraventricular
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of Modified Valsalva maneuvre in people with Supraventricular Tachycardia, run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanne Gworek, MD (+32474521990, hanne.gw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Was Modified Valsalva maneuver used in this patient? (time frame: Moment of treatment, no follow up. Up to 1 year since start of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.