Trial Title:
In-hospital Stellate Ganglion Block for Arrhythmic Storm
NCT ID:
NCT05720936
Condition:
Arrhythmic Storm
Conditions: Official terms:
Ganglion Cysts
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Percutaneous stellate ganglion block (PSGB)
Description:
Both 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
Arm group label:
patients with electric storm
Summary:
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.
Detailed description:
This is a multicenter international observational retrospective and prospective short
term (24 hours) longitudinal study, promoted and coordinated by the Fondazione IRCCS
Policlinico San Matteo (Pavia, Italy).
Materials and methods 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.
Inclusion criteria:
All the patients presenting with an arrhythmic storm defined as more than three sustained
ventricular arrhythmias in 24 hours refractory to the standard medical treatment.
Exclusion criteria
- A previous history of cardiac sympathicectomy
- Having a neck judged by the doctor as non-suitable for the procedure (previous neck
surgery, previous burns, presence of large scars, thyroid goiter)
PSGB technique
Both 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 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.
Study endpoints The primary endpoint is the effectiveness of the PSGB expressed by the
reduction of arrhythmic relapses [number of Direct Current (DC) shocks or
Anti-Tachycardia Pacing ATP] in the 12 hours immediately after the PSGB as compared to
the 6 hours immediately preceding the PSGB of at least 50%.
The secondary endpoints are:
1. The comparison of the number of shocks 12h before and 12h after the procedure
2. The feasibility of the procedure 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
3. The comparison of the effectiveness endpoint in patients with and without the
appearance of anisocoria
4. The comparison of effectiveness between patients who will receive "anatomical" PSGB
and those who will receive echo-guided PSGB
5. The comparison of effectiveness between patients who will receive anaesthetic
infusion in the site of PSGB as compared to those who will not.
Statistics Sample size: The investigators plan to enroll patients satisfying the
inclusion/exclusion criteria over a time horizon of 5 years. Based on our previous
experience over the previous 18 months (enrollment of 8 patients) about 5 patients per
year are though to be enrolled, thus reaching a sample size 33 patients in the Pavia
Center. The success is effectiveness to be not less then 90%, based on our historical
cohort. This will yield a confidence interval of 76% to 98%, corresponding to a precision
of 11%. Also, with this sample size it will be able to exclude an effectiveness of 70%
(considered as the lower bound of acceptability) with a power of 94% (alpha 2-sided 5%).
With the inclusion of further centers, the increased sample size will allow an increased
precision of the estimates; for instance for 100 patients precision would be 6.5%.
Statistical analysis: Data will be described with the mean and standard deviation or the
median and 25th-75th percentile if continuous and counts and percent if categorical.
For the analysis of the primary endpoint the rate of effectiveness together with its 95%
exact binomial confidence interval will be computed.
Data management Data will be collected using the REDCap platform. A personal and password
protected account will be created for each investigator who will be able to access only
to the data form his/her center.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- age ≥ 18 years,
- presence of arrhythmic storm defined as more than three sustained ventricular
arrhythmias in 24 hours refractory to the standard medical treatment.
Exclusion Criteria:
- 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)
Both 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 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria.
Address:
City:
Alessandria
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Edoardo Gandolfi, MD
Email:
edogand@hotmail.com
Investigator:
Last name:
Edoardo Gandolfi, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Maggiore di Bologna
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ganmarco Iannopollo, MD
Email:
gianmarco.iannopollo@libero.it
Investigator:
Last name:
Gianmarco Iannopollo, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Simone Savastano, MD
Phone:
+390382/501590
Email:
s.savastano@smatteo.pv.it
Contact backup:
Last name:
Alessia Currao, PharmD
Phone:
+390382/501590
Email:
a.currao@smatteo.pv.it
Investigator:
Last name:
Simone Savastano, MD
Email:
Principal Investigator
Investigator:
Last name:
Alessia Currao, PharmD
Email:
Sub-Investigator
Investigator:
Last name:
Roberto Rordorf, MD
Email:
Sub-Investigator
Investigator:
Last name:
Enrico Baldi, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sara Compagnoni, MD
Email:
Sub-Investigator
Facility:
Name:
P.O. "San Michele" dell'ARNAS "G. Brotzu" di Cagliari
Address:
City:
Cagliari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marco Corda, MD
Email:
marcocorda2@aob.it
Investigator:
Last name:
Marco Corda, MD
Email:
Principal Investigator
Investigator:
Last name:
Matteo Casula, MD
Email:
Sub-Investigator
Facility:
Name:
Istituto clinico Humanitas Mater Domini di Castellanza
Address:
City:
Castellanza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Domenico Zagari, MD
Email:
domenico.zagari@mc.humanitas.it
Investigator:
Last name:
Domenico Zagari, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale San Biagio di Domodossola
Address:
City:
Domodossola
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Simone Persamperi, MD
Email:
simone.persampieri@gmail.com
Investigator:
Last name:
Simone Persamperi, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Misericordia di Grosseto.
Address:
City:
Grosseto
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco De Sensi, MD
Email:
checcodes@gmail.com
Investigator:
Last name:
Francesco De Sensi
Email:
Principal Investigator
Facility:
Name:
A.O.U. Policlinico "G. Martino" di Messina.
Address:
City:
Messina
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pasquale Crea, MD
Email:
pasqualecrea85@gmail.com
Investigator:
Last name:
Pasquale Crea, MD
Email:
Principal Investigator
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda di Milano
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Claudia Colombo, MD
Email:
claudia.colombo@ospedaleniguarda.it
Investigator:
Last name:
Claudia Colombo, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Auxologico Italiano
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giovanni Battista Perego, MD
Email:
perego@auxologico.it
Facility:
Name:
A.O.U. Maggiore della Carità di Novara
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gabriele Dell'Era, MD
Email:
gdellera@gmail.com
Investigator:
Last name:
Gabriele Dell'Era, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale S. Maria della Misericordia - Perugia
Address:
City:
Perugia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Notaristefano, MD
Email:
f.notaristefano@ospedale.perugia.it
Investigator:
Last name:
Francesco Notaristefano, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione PTV Policlinico Tor Vergata di Roma
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Sangiorgi, MD
Email:
giuseppe.sangiorgi@ptvonline.it
Investigator:
Last name:
Giuseppe Sangiorgi, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Fatebenefratelli di Roma.
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Filippo Cauti, MD
Email:
filippocauti@hotmail.it
Investigator:
Last name:
Filippo Cauti, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Molinette di Torino
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gaetano M De Ferrari, MD
Email:
gaetanomaria.deferrari@unito.it
Contact backup:
Last name:
Veronica Dusi, MD
Email:
veronica.dusi@gmail.com
Investigator:
Last name:
Gaetano M De Ferrari, MD
Email:
Principal Investigator
Investigator:
Last name:
Veronica Dusi, MD
Email:
Sub-Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata - Verona
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giacomo Mugnai, MD
Email:
giacomo.mugnai@aovr.veneto.it
Investigator:
Last name:
Giacomo Mugnai, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Cardiocentro Ticino
Address:
City:
Lugano
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Angelo Auricchio, MD
Email:
angelo.auricchio@cardiocentro.org
Investigator:
Last name:
Angelo Auricchio, MD
Email:
Principal Investigator
Start date:
January 2017
Completion date:
December 2025
Lead sponsor:
Agency:
Fondazione IRCCS Policlinico San Matteo di Pavia
Agency class:
Other
Source:
Fondazione IRCCS Policlinico San Matteo di Pavia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05720936
