Medical Etiology, Out-Of-Hospital Cardiac Arrest, Refractory Ventricular Arrhythmias, Shockable Rhythm, Ventricular Fibrillation Sustained
Conditions
Keywords
PSGB, Percutaneous Stellate Ganglion Block, Cardiac Arrest, OHCA, Ventricular Arrhythmias, VA, Ventricular Fibrillation, VF, PLSGB, refractory
Brief 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.
Detailed 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).
Interventions
PROCEDUREPSGB
Percutaneous stellate ganglion block: injection of 10 mL of local anaesthetic (lidocaine 2%) at the C6 level using the anatomic technique or the echo-guided technique The anaesthetic that will be used for PSGB is lidocaine.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
University of Pavia
AREU - Agenzia Regionale Emergenza Urgenza
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients with an OHCA, occurred in the Province of Pavia, in which the first rhythm 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 ACLS algorithm;
Exclusion criteria
* Patients in which the cause of the cardiac arrest is non-medical following Utstein-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 of big scar, thyroid goiter, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ventricular fibrillation termination | From L-PSGB execution to 10 minutes after the L-PSGB execution | Primary electrocardiographic outcome: we will measure the rate of VF termination after L-PSGB, namely the number of patients no longer in VF after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of return of spontaneous circulation (ROSC) | at hospital admission (assessed within 24 hours after L-PSGB) | To assess whether the rate of return of spontaneous circulation is higher in the patients treated with L-PSGB as compared to historical controls. |
| Rate of return of spontaneous circulation (ROSC) if anisocoria is present | at hospital admission (assessed within 24 hours after L-PSGB) | To assess whether the rate of ROSC is higher in the patients treated with L-PSGB and in which anisocoria is present after the L-PSGB, but not before L-PSGB |
| Survived event | at hospital admission (assessed within 24 hours after L-PSGB) | To assess whether the rate of ROSC until admission and transfer of care to the receiving hospital is higher in the patients treated with L-PSGB as compared to historical controls. |
| Survived event if anisocoria present | at hospital admission (assessed within 24 hours after L-PSGB) | To assess whether the rate of ROSC until admission and transfer of care to the receiving hospital is higher in the patients treated with PSGB and in which anisocoria is present after the L-PSGB, but not before L-PSGB |
| Survival at hospital discharge | Up to hospital discharge (estimated within 30 days after L-PSGB) | To assess whether the survival rate at hospital discharge is higher in the patients treated with L-PSGB. |
| Survival at hospital discharge if anisocoria present | Up to hospital discharge (estimated within 30 days after L-PSGB) | To assess whether the survival rate at hospital discharge is higher in the patients treated with PSGB and in which anisocoria is present after the L-PSGB, but not before L-PSGB |
| Survival with good neurological outcome | 1 month after the cardiac arrest | To assess whether the survival rate with good neurological outcome (CPC 1 or 2) at 1 month after the event is higher in the patients treated with L-PSGB |
| Survival with good neurological outcome if anisocoria present | 1 month after the cardiac arrest | To assess whether the survival rate with good neurological outcome (CPC 1 or 2) at 1 month after the event is higher in the patients treated with PSGB and in which anisocoria is present after the L-PSGB, but not before L-PSGB. |
| Rate of rhythm conversion after first defibrillation | During resuscitation | The rate of rhythm conversion at the first defibrillation after the L-PSGB |
| Rate of rhythm conversion after second defibrillation | During resuscitation | The rate of rhythm conversion at the second defibrillation after the L-PSGB |
| Rate of complications | Up to hospital discharge (estimated within 30 days after L-PSGB) | The occurrence of complications associated with PSGB in the pre-hospital setting |
| Feasibility of PSGB in the pre-hospital setting | Up to 24 hours after the event | The feasibility and practicability of L-PSGB in the pre-hospital setting based on a questionnaire filled out by the physician who performed the L-PSGB. Physicians who had performed L-PSGB were asked to complete a questionnaire regarding the feasibility of the technique in the prehospital setting, the practicality of its application compared with procedures routinely performed in the prehospital setting, and any complications encountered. Responses were rated on a 10-point Likert scale (1 = no feasibility; 10 = perfect feasibility). |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORSimone Savastano, MD
Cardiology Department, Fondazione IRCCS Policlinico San Matteo of Pavia (Italy)
Outcome results
None listed