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

August 11, 2026 updated by: Simone Savastano, Fondazione IRCCS Policlinico San Matteo di Pavia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
    • Pavia
      • Pavia, Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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.)

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.).
Procedure: PSGB
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 more than 4 shocks) enrolled in the Out Of Hospital Cardiac Arrest Registry of the Province of Pavia ("Lombardia CARe").

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of ventricular fibrillation termination
Time Frame: 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
From L-PSGB execution to 10 minutes after the L-PSGB execution

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of return of spontaneous circulation (ROSC)
Time Frame: 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.
at hospital admission (assessed within 24 hours after L-PSGB)
Rate of return of spontaneous circulation (ROSC) if anisocoria is present
Time Frame: 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
at hospital admission (assessed within 24 hours after L-PSGB)
Survived event
Time Frame: 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.
at hospital admission (assessed within 24 hours after L-PSGB)
Survived event if anisocoria present
Time Frame: 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
at hospital admission (assessed within 24 hours after L-PSGB)
Survival at hospital discharge
Time Frame: 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.
Up to hospital discharge (estimated within 30 days after L-PSGB)
Survival at hospital discharge if anisocoria present
Time Frame: 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
Up to hospital discharge (estimated within 30 days after L-PSGB)
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 or 2) at 1 month after the event is higher in the patients treated with L-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 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.
1 month after the cardiac arrest
Rate of rhythm conversion after first defibrillation
Time Frame: During resuscitation
The rate of rhythm conversion at the first defibrillation after the L-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 L-PSGB
During resuscitation
Rate of complications
Time Frame: Up to hospital discharge (estimated within 30 days after L-PSGB)
The occurrence of complications associated with PSGB in the pre-hospital setting
Up to hospital discharge (estimated within 30 days after L-PSGB)
Feasibility of PSGB in the pre-hospital setting
Time Frame: 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).
Up to 24 hours after the event

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pavia
AREU - Agenzia Regionale Emergenza Urgenza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simone Savastano, MD, Cardiology Department, Fondazione IRCCS Policlinico San Matteo of Pavia (Italy)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIVE 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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