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JOURNAL ONKOLOGIE – STUDIE
STAR

In-hospital Stellate Ganglion Block for Arrhythmic Storm

Rekrutierend

NCT-Nummer:
NCT05720936

Studienbeginn:
Januar 2017

Letztes Update:
08.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Ganglion Cysts

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
IRCCS Policlinico S. Matteo

Collaborator:
-

Kontakt

Studienlocations
(3 von 17)

Fondazione IRCCS Policlinico San Matteo
27100 Pavia
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Simone Savastano, MD
Phone: +390382/501590
E-Mail: s.savastano@smatteo.pv.it

Alessia Currao, PharmD
Phone: +390382/501590
E-Mail: a.currao@smatteo.pv.it» Ansprechpartner anzeigen
Ospedale Molinette di Torino
Torino
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Gaetano M De Ferrari, MD
E-Mail: gaetanomaria.deferrari@unito.it

Veronica Dusi, MD
E-Mail: veronica.dusi@gmail.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. reduction of arrhythmic relapses after PSGB (Time Frame - 12h before and 12h after the procedure):
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.



Secondary outcome:

1. reduction of arrhythmic relapses after PSGB (Time Frame - 12h before and 12h after the procedure):
the effectiveness of the technique will be evaluated by the comparison of the number of shocks before and after the procedure

2. complication rate related to PSGB (Time Frame - 12 hours after the procedure):
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

3. relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB (Time Frame - 12h before and 12h after the procedure):
The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria

4. relationship between the approach used and the reduction of arrhythmic relapses after PSGB (Time Frame - 12h before and 12h after the procedure):
The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB.

5. relationship between the administration type and the reduction of the arrhythmic relapses after PSGB. (Time Frame - 12h before and 12h after the procedure):
The comparison of effectiveness between patients who will receive continuous anesthetic infusion and patients who will receive a single bolus in the site of PSGB.

Geprüfte Regime

  • Percutaneous stellate ganglion block (PSGB):
    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

Quelle: ClinicalTrials.gov


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