A Multicenter Observational Study on In-hospital Stellate Ganglion Block for Arrhythmic Storm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 38
- 主要终点
- reduction of arrhythmic relapses after PSGB
研究概览
简要总结
Arrhythmic storm is a real emergency and its treatment could be challenging. Antiarrhythmic drugs are few and often ineffective. Neuromodulation has been grown in evidences but no large multicentric studies are present in literature about safety and effectiveness of Percutaneous Stellate Ganglion Block (PSGB). Patients with an electrical storm refractory to at least one antiarrhythmic drug will receive PSGB and will be enrolled in the present study.
The number of defibrillations before and after the treatment will be compared, complications will be annotated.
详细描述
This is an international multicenter observational retrospective and prospective short term (24 hours) longitudinal study, promoted and coordinated by the Fondazione IRCCS Policlinico San Matteo of Pavia (Italy).
Materials and methods:
All the patients who will meet the inclusion criteria will be enrolled in the study. Conscious patients with a sufficient free interval between arrhythmic relapses will sign the informed consent for the procedure and for data collection (attached at the study protocol) before the procedure. In case of unconscious patients the medical doctor will perform the procedure being in an emergency situation and the inform consent for data collection will be signed afterward once possible.
Inclusion criteria:
All the patients presenting with an arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years,
- •presence of arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment.
排除标准
- •A previous history of cardiac sympathicectomy
- •Having a neck judged unsuitable for the procedure (previous neck surgery, previous burns, presence of large scars, thyroid goiter)
- •Both the two approaches present in literature and commonly used for this technique are allowed for the study:
- •The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion
- •The "echo-guided" approach Regardless to the approach (anatomical or echo-guided) the doctor will be able to choose, according to the clinical characteristics of the patients, whether to perform a single shot injection of anesthetic or a continuous infusion of anesthetic. In the second case a catheter will be left in place and connected to an infusion pump.
结局指标
主要结局
reduction of arrhythmic relapses after PSGB
时间窗: 12h before and 12h after the procedure
effectiveness of the PSGB expressed by the reduction of arrhythmic relapses (number of DC shocks or anti-tachycardia pacing ATP) of at least 50% after PSGB.
次要结局
- reduction of arrhythmic relapses after PSGB(12h before and 12h after the procedure)
- complication rate related to PSGB(12 hours after the procedure)
- relationship between the administration type and the reduction of the arrhythmic relapses after PSGB.(12h before and 12h after the procedure)
- relationship between the approach used and the reduction of arrhythmic relapses after PSGB(12h before and 12h after the procedure)
- relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB(12h before and 12h after the procedure)
研究者
Simone Savastano
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia