In-hospital Stellate Ganglion Block for Arrhythmic Storm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
About this trial
Arrhythmic storm is a real emergency and its treatment could be challenging. Antiarrhythmic drugs are few and often ineffective. Neuromodulation has been grown in evidences but no large multicentric studies are present in literature about safety and effectiveness of Percutaneous Stellate Ganglion Block (PSGB). Patients with an electrical storm refractory to at least one antiarrhythmic drug will receive PSGB and will be enrolled in the present study.
The number of defibrillations before and after the treatment will be compared, complications will be annotated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years,
presence of arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment.
Disqualifiers
A previous history of cardiac sympathicectomy
Having a neck judged unsuitable for the procedure (previous neck surgery, previous burns, presence of large scars, thyroid goiter)
The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion
The "echo-guided" approach Regardless to the approach (anatomical or echo-guided) the doctor will be able to choose, according to the clinical characteristics of the patients, whether to perform a single shot injection of anesthetic or a continuous infusion of anesthetic. In the second case a catheter will be left in place and connected to an infusion pump.
Trial population
All the patients who will meet the inclusion criteria will be enrolled in the study. Conscious patients with a sufficient free interval between arrhythmic relapses will sign the informed consent for the procedure and for data collection (attached at the study protocol) before the procedure. In case of unconscious patients the medical doctor will perform the procedure being in an emergency situation and the inform consent for data collection will be signed afterward once possible.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Percutaneous stellate ganglion block (PSGB)
Procedure/SurgeryBoth the two approaches present in literature and commonly used for this technique are allowed for the study: * The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion * The "echo-guided" approach
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: patients with electric storm1 intervention
Trial outcomes
Primary outcomes
1
reduction of arrhythmic relapses after PSGB
effectiveness of the PSGB expressed by the reduction of arrhythmic relapses (number of DC shocks or anti-tachycardia pacing ATP) of at least 50% after PSGB.
Time frame
12h before and 12h after the procedureSecondary outcomes
1
reduction of arrhythmic relapses after PSGB
the effectiveness of the technique will be evaluated by the comparison of the number of shocks before and after the procedure
Time frame
12h before and 12h after the procedure2
complication rate related to PSGB
The feasibility of the procedure will be expressed as the number of complications within 12 hours from the procedure. The following complications will be considered: * Simple hematoma * Symptoms due to anesthetic absorbance * Hematoma requiring intervention * Intravascular injection without complication * Intravascular injection with complication * Brachial plexus damage * Simple vascular damage * Vascular damage requiring intervention
Time frame
12 hours after the procedure3
relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB
The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria
Time frame
12h before and 12h after the procedure4
relationship between the approach used and the reduction of arrhythmic relapses after PSGB
The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB.
Time frame
12h before and 12h after the procedureSponsors and contacts
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Source ClinicalTrials.gov