Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720936
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-01-07
Brief Title:
In-hospital Stellate Ganglion Block for Arrhythmic Storm
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
A Multicenter Observational Study on In-hospital Stellate Ganglion Block for Arrhythmic Storm
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief 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
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 Chassaignacs 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 inclusionexclusion 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 65
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 hisher center
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 Chassaignacs 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 inclusionexclusion 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 65
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 hisher center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None