Out-Of-Hospital Cardiac ArrestLIVENCT04168970
Percutaneous Left Stellate Ganglion Block In Out-of-hospital Cardiac Arrest Due to Refractory VEntricular Arrhythmias (LIVE Study)
An observational study of Out-Of-Hospital Cardiac Arrest and Ventricular Fibrillation Sustained, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation Sustained, Shockable Rhythm
- What is being tested?
- PSGB
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 62 participants
- Where
- 2 sitesItaly
- Study dates
- 12 Jun 2019to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
About this study
Official title: 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.
Read the 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).
- Conditions
- Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation Sustained, Shockable Rhythm, Medical Etiology, Refractory Ventricular Arrhythmias
- Being tested
- PSGB
- Keywords
- PSGB, Percutaneous Stellate Ganglion Block, Cardiac Arrest, OHCA, Ventricular Arrhythmias, VA, Ventricular Fibrillation, VF, PLSGB, refractory
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSGBProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: Procedure: PSGB | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Rate of ventricular fibrillation termination
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
Measured: From L-PSGB execution to 10 minutes after the L-PSGB execution
Secondary outcomes (12)
Rate of return of spontaneous circulation (ROSC)
To assess whether the rate of return of spontaneous circulation is higher in the patients treated with L-PSGB as compared to historical controls.
Measured: at hospital admission (assessed within 24 hours after L-PSGB)
Rate of return of spontaneous circulation (ROSC) if anisocoria is present
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
Measured: at hospital admission (assessed within 24 hours after L-PSGB)
Survived event
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.
Measured: at hospital admission (assessed within 24 hours after L-PSGB)
Survived event if anisocoria present
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
Measured: at hospital admission (assessed within 24 hours after L-PSGB)
Survival at hospital discharge
To assess whether the survival rate at hospital discharge is higher in the patients treated with L-PSGB.
Measured: Up to hospital discharge (estimated within 30 days after L-PSGB)
Survival at hospital discharge if anisocoria present
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
Measured: Up to hospital discharge (estimated within 30 days after L-PSGB)
Survival with good neurological outcome
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
Measured: 1 month after the cardiac arrest
Survival with good neurological outcome if anisocoria present
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.
Measured: 1 month after the cardiac arrest
Rate of rhythm conversion after first defibrillation
The rate of rhythm conversion at the first defibrillation after the L-PSGB
Measured: During resuscitation
Rate of rhythm conversion after second defibrillation
The rate of rhythm conversion at the second defibrillation after the L-PSGB
Measured: During resuscitation
Rate of complications
The occurrence of complications associated with PSGB in the pre-hospital setting
Measured: Up to hospital discharge (estimated within 30 days after L-PSGB)
Feasibility of PSGB in the pre-hospital setting
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).
Measured: Up to 24 hours after the event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start12 Jun 2019
- Primary completion31 Dec 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia, AREU - Agenzia Regionale Emergenza Urgenza
- Responsible party
- Principal investigator, Simone Savastano, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Simone Savastano, MD, Principal investigator, Cardiology Department, Fondazione IRCCS Policlinico San Matteo of Pavia (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168970
- Sponsor's protocol ID
- LIVE Study
- Acronym
- LIVE
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Left Stellate Ganglion Block In Out-of-hospital Cardiac Arrest Due to Refractory VEntricular Arrhythmias (LIVE)
- ClinicalTrials.gov ID
- NCT04168970
- Acronym / sponsor ID
- LIVE / LIVE Study
- Conditions
- Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation Sustained, Shockable Rhythm, Medical Etiology, Refractory Ventricular Arrhythmias
- Keywords
- PSGB, Percutaneous Stellate Ganglion Block, Cardiac Arrest, OHCA, Ventricular Arrhythmias, VA, Ventricular Fibrillation, VF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- University of Pavia, AREU - Agenzia Regionale Emergenza Urgenza
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSGB group | – | Procedure: PSGBMD 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.). |
| 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"). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSGBPercutaneous 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. | Procedure or surgery | PSGB group |
Primary outcome
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
12 secondary outcomes
Rate of return of spontaneous circulation (ROSC)
Time frame: 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)
Survived event
Time frame: 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)
Survival at hospital discharge
Time frame: 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)
Survival with good neurological outcome
Time frame: 1 month after the cardiac arrest
Survival with good neurological outcome if anisocoria present
Time frame: 1 month after the cardiac arrest
Rate of rhythm conversion after first defibrillation
Time frame: During resuscitation
Rate of rhythm conversion after second defibrillation
Time frame: During resuscitation
Rate of complications
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Savastano, MD principal investigator
Cardiology Department, Fondazione IRCCS Policlinico San Matteo of Pavia (Italy)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest and Ventricular Fibrillation Sustained, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ventricular fibrillation termination (time frame: From L-PSGB execution to 10 minutes after the L-PSGB execution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.