- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04168970
Percutaneous Left Stellate Ganglion Block In Out-of-hospital Cardiac Arrest Due to Refractory VEntricular Arrhythmias (LIVE Study) (LIVE)
Percutaneous Left Stellate Ganglion Block In Out-of-hospital Cardiac Arrest Due to Refractory VEntricular Arrhythmias
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Simone Savastano, MD
- Phone Number: +39 0382501276
- Email: s.savastano@smatteo.pv.it
Study Contact Backup
- Name: Enrico Baldi, MD
- Email: enrico.baldi@unipv.it
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:
- Enrico Baldi, MD
- Email: enrico.baldi@unipv.it
-
Contact:
- Simone Savastano, MD
- Email: s.savastano@smatteo.pv.it
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIVE Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Out-Of-Hospital Cardiac Arrest
-
Medical University of ViennaLudwig Boltzmann Institute Digital Health and Patient Safety; Emergency Medical...RecruitingCardiac Arrest, Out-Of-HospitalAustria
-
University Medical Centre MariborOHK Medical DevicesRecruiting"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".Cardiac Arrest | Out of Hospital Cardiac ArrestSlovenia
-
National Taiwan University HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
Far Eastern Memorial HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
King's College LondonKing's College Hospital NHS Trust; London Ambulance Service NHS TrustNot yet recruiting
-
Wroclaw Medical UniversityWroclaw Emergency Medical ServicesRecruiting
-
Sunnybrook Health Sciences CentrePrescott-Russell Paramedic Service; Peterborough Paramedic Service; Bruce County... and other collaboratorsRecruiting
-
Emergency Medical Services, Capital Region, DenmarkTrygFonden, Denmark; Danish Heart Foundation; Zoll Medical CorporationRecruitingOut-Of-Hospital Cardiac ArrestDenmark
-
Guy's and St Thomas' NHS Foundation TrustLondon School of Hygiene and Tropical Medicine; King's College London; King's... and other collaboratorsActive, not recruitingOut-Of-Hospital Cardiac ArrestUnited Kingdom
-
National Taiwan University HospitalCompletedOut-Of-Hospital Cardiac ArrestTaiwan
Clinical Trials on PSGB
-
IRCCS Policlinico S. MatteoRecruiting
-
Yonsei UniversityUnknownRefractory Ventricular TachycardiaKorea, Republic of