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

March 7, 2024 updated by: Simone Savastano, IRCCS Policlinico S. Matteo

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

A prospective uncontrolled 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 whether the rate of 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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

This is a prospective uncontrolled study. All patients meeting the inclusion criteria will be consecutively enrolled in the study. 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.). 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 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 patients with prehospital 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 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%, which is 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 encountered. The responses will be scored from 1 to 10 (1=perfect feasibility; 10=no 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 Cardiac Arrest Registry of the Province of Pavia from 1 January 2016 to 31 December 2017.

Study Type

Observational

Enrollment (Estimated)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Sub-Investigator:
          • Guido Tavazzi, MD
        • Sub-Investigator:
          • Enrico Baldi, MD
        • Sub-Investigator:
          • Veronica Dusi, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alessandra Palo, MD
        • Sub-Investigator:
          • Vito Sgromo, MD
        • Sub-Investigator:
          • Antonella Brancaglione, MD
        • Sub-Investigator:
          • Enrico Contri, MD
        • Sub-Investigator:
          • Gaetano Maria De Ferrari, MD
        • Sub-Investigator:
          • Luca Caneva, MD
        • Sub-Investigator:
          • Luca Civardi, MD
        • Sub-Investigator:
          • Andrea Comelli, MD
        • Sub-Investigator:
          • Sergio Cortesi, MD
        • Sub-Investigator:
          • Paolo Fumagalli, MD
        • Sub-Investigator:
          • Bruno Lusona, MD
        • Sub-Investigator:
          • Giuseppe Maggio, MD
        • Sub-Investigator:
          • Marco Pozzi, MD
        • Sub-Investigator:
          • Filippo Repossi, MD
        • Sub-Investigator:
          • Roberto Rizzardi, MD
        • Sub-Investigator:
          • Fabio Sciutti, MD
        • Sub-Investigator:
          • Anna Aliberti, MD
        • Sub-Investigator:
          • Stefania Brancati, MD
        • Sub-Investigator:
          • Marinella Fuardo, MD
        • Sub-Investigator:
          • Manuela Guerci, MD
        • Sub-Investigator:
          • Silvia Mongodi, MD
        • Sub-Investigator:
          • Anita Orlando, MD
        • Sub-Investigator:
          • Greta Pamploni, MD
        • Sub-Investigator:
          • Pietro Pettenazza, MD
        • Sub-Investigator:
          • Sara Richiusa, MD
        • Sub-Investigator:
          • Immacolata Romeo, MD
        • Sub-Investigator:
          • Debora Sportiello, MD
        • Sub-Investigator:
          • Monica Toscani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with an OHCA occurred in the Province of Pavia in which the first rhythm was a shockable one and with at least three episode of VT/VF during the out-of-hospital resuscitation

Description

Inclusion Criteria:

  • All patients with an OHCA occurred in the Province of Pavia in which the first rhythm was a shockable one

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PSGB group
MD will perform PSGB using Lidocaine. 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. PSGB will be performed 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.).
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.
Control group
Historical cohort of patients with the same OHCA characteristics (first shockable rhythm and who received more than 4 shocks) enrolled in the Cardiac Arrest Registry of the Province of Pavia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: Up to hospital discharge (on average 15 days after the event)
The occurrence of complications associated with PSGB in the pre-hospital setting
Up to hospital discharge (on average 15 days after the event)
Feasibility of PSGB in the pre-hospital setting
Time Frame: Up to 24 hours after the event
The feasibility and practicability of PSGB in the pre-hospital setting based on a questionnaire filled out by the physician who performed the PSGB
Up to 24 hours after the event
Survived event
Time Frame: Up to hospital admission
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 as compared to historical controls.
Up to hospital admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of rhythm conversion after first defibrillation
Time Frame: During resuscitation
The rate of rhythm conversion at the first defibrillation after the PSGB
During resuscitation
Rate of rhythm conversion after second defibrillation
Time Frame: During resuscitation
The rate of rhythm conversion at the second defibrillation after the PSGB
During resuscitation
Rate of ROSC if anisocoria is present
Time Frame: Up to hospital admission
To assess whether the rate of ROSC is higher in the patients treated with PSGB and in which anisocoria is present after the PSGB, but not before PSGB
Up to hospital admission
Rate of ROSC
Time Frame: Up to hospital admission
To assess whether the rate of ROSC is higher in the patients treated with PSGB
Up to hospital admission
Survived event if anisocoria present
Time Frame: Up to hospital admission
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 PSGB, but not before PSGB
Up to hospital admission
Survival at hospital discharge
Time Frame: Up to hospital discharge (on average 15 days after the event)
To assess whether the survival rate at hospital discharge is higher in the patients treated with PSGB.
Up to hospital discharge (on average 15 days after the event)
Survival at hospital discharge if anisocoria present
Time Frame: Up to hospital discharge (on average 15 days after the event)
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 PSGB, but not before PSGB
Up to hospital discharge (on average 15 days after the event)
Survival with good neurological outcome
Time Frame: 1 month after the cardiac arrest
To assess whether the survival rate with good neurological outcome (CPC 1 ore 2) at 1 month after the event is higher in the patients treated with PSGB
1 month after the cardiac arrest
Survival with good neurological outcome if anisocoria present
Time Frame: 1 month after the cardiac arrest
To assess whether the survival rate with good neurological outcome (CPC 1 ore 2) at 1 month after the event is higher in the patients treated with PSGB and in which anisocoria is present after the PSGB, but not before PSGB.
1 month after the cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

September 14, 2019

First Submitted That Met QC Criteria

November 16, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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