Percutaneous Left Stellate Ganglion Block In Out-of-hospital Cardiac Arrest Due to Refractory VEntricular Arrhythmias (LIVE Study)

Last updated: August 11, 2026
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Overall Status: Completed

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Arrhythmia

Heart Disease

Treatment

PSGB

Clinical Study ID

NCT04168970
LIVE Study
  • Ages 18-100
  • All Genders

Study Summary

This is an observational, prospective study to verify the feasibility and practicability of percutaneous stellate ganglion block (PSGB) in patient suffering from a refractory out-of-hospital cardiac arrest (OHCA) due to a shockable rhythm and the eventual occurrence of complication related to it. The study will also assess the rate of ventricular fibrillation termination and the return of spontaneous circulation (ROSC) until admission and transfer of care to the receiving hospital is higher in the patients treated with PSGB as compared to historical controls.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients with an OHCA, occurred in the Province of Pavia, in which the firstrhythm was a shockable one and in which the cause of the cardiac arrest is medical (following Utstein-style 2014).

  • Patients who received L-PSGB after at least 4 unsuccessful shocks during ACLSalgorithm;

Exclusion

Exclusion Criteria:

  • Patients in which the cause of the cardiac arrest is non-medical followingUtstein-style 2014 (trauma, overdose, drowning, electrocution, asphyxia, etc.)

  • Patients who has an anisocoria at the arrival of medical doctor on the scene.

  • Patients whose neck is judge unsuitable for PSGB by the operator (i.e. presence ofbig scar, thyroid goiter, etc.)

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: PSGB
Phase:
Study Start date:
June 12, 2019
Estimated Completion Date:
May 31, 2026

Study Description

All patients meeting the inclusion/exclusion eligibility criteria will be consecutively enrolled in the study. The decision to perform PSGB or not and the type of technique (anatomic or echo-guided) is left to the EMS rescue team medical doctor (MD), according to clinical practice (standard of care).

The Emergency Medical System (EMS) rescue team medical doctor (MD) will be asked to perform PSGB after all the actions provided in the ACLS algorithm and which are considered useful in the clinical situation (intubation and ventilation, administration of iv/io adrenaline, amiodarone or lidocaine, use of mechanical chest compression, etc.). Considering that the PGSB is useful for the treatment of refractory Ventricular Arrhythmias, the PGSB will be performed after the administration of the 4th shock, if the 3rd shock was unsuccessful in restoring a stable perfusing rhythm, considering all the shocks administered both by an AED or by manual defibrillator. The evaluation of the effectiveness of the 3rd shock will be carried out at the end of the two-minute cycle after shock delivery, as recommended by the Guidelines. If the MD will arrive on the scene after the delivery of the 3rd shock, the PSGB should be executed as soon as possible after performing all the actions which are considered useful in the clinical situation. The MD, based on his confidence, can choose to use the anatomic technique or the echo-guided PSGB technique. The technique will be performed in the pre-hospital setting. Those patients with refractory OHCA transported with ongoing ACLS who receive the fourth shock once in the Emergency Department will be also considered. On the contrary, the patients with pre-Hospital ROSC who suffer a new cardiac arrest once in the Emergency Department won't be considered in the present study. The MD will be asked to evaluate also the presence of anisocoria immediately before the PSGB and 1-2 minutes after the PSGB. In case of absence of anisocoria 2 minutes after PSGB, MD can try PSGB another time. The anaesthetic that will be used for PSGB is Lidocaine 2% (10cc bolus), which is already available among EMS drugs. Considering the setting and the need of a rapid effect of the anaesthetic, it is expected that the anaesthetic used will be lidocaine 2%, which is also already available among EMS drugs.

After the end of the event, the MD will be asked to fill in a Questionnaire regarding the feasibility of the technique in the pre-hospital setting, the practicability of its implementation compared to the usual procedures performed in the pre-hospital setting and any problems/complications encountered. The responses will be scored from 1 to 10 (1=no feasibility; 10=perfect feasibility). All eventual complications associated with PSGB will be carefully recorded.

The effectiveness of the PSGB will be evaluated if at least one shock will be delivered after the execution of PSGB.

The data will be compared to our historical cohort of patients with the same OHCA characteristics (first shockable rhythm and who received more than 4 shocks) enrolled in the Out-of-Hospital Cardiac Arrest Registry "Lombardia CARe" in the Province of Pavia (Italy).

Connect with a study center

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Pavia 27100
    Italy

    Site Not Available

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