Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Number of Participants Who Achieved ROSC (return of spontaneous circulation)
研究概览
简要总结
The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.
详细描述
Nontraumatic OHCA patients arriving at the 2 participating hospitals between the ages of 20 to 80 will be eligible. If the patient meets the enrollment criteria, he/she will be randomized into the control group (treatment with conventional ACLS according to the 2020 AHA guideline) or the REBOA group (ACLS according to the 2020 AHA guideline with REBOA application). A sheath catheter is inserted with ultrasound guidance to gain access to the common femoral artery in both groups. This is followed by insertion of the REBOA catheter, if the patient is allocated into the intervention group. The aortic balloon is inflated. If ROSC is achieved, the balloon is deflated slowly. Patients who achieve ROSC will receive post cardiac arrest management according to the 2020 AHA guideline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult nontraumatic OHCA
- •Witnessed arrest
- •Arrival at ER from 9AM to 5PM (in each country)
排除标准
- •age below 20 years old or over 80 years old,
- •traumatic cardiac arrest,
- •those with unwitnessed cardiac arrest,
- •pregnant patients,
- •patients who have already achieved ROSC upon arrival at the emergency department
- •pre-cardiac arrest cerebral performance category of 3-4
- •those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding)
- •those suspected of having aortic disease, such as dissection, intramural hematoma, or aneurysm, by bedside ultrasound performed immediately after ED arrival or have a previous history of aortic disease
- •whose legal representative has requested termination of resuscitation efforts before study enrollment
- •declared dead at scene before randomization
- •Patients who meet the criteria for extracorporeal cardiopulmonary resuscitation (ECPR), and therefore the decision is made to perform ECPR, will not be enrolled. The ECPR criteria applies when all of the following criteria are met: pre-cardiac arrest CPC of 1-2, witnessed cardiac arrest with bystander CPR, ages between 20-70, initial shockable rhythm, ECMO pump-on available within 60 minutes of onset of cardiac arrest, and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage renal failure.
研究组 & 干预措施
Control
Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.
REBOA
After enrollment and randomization, patients allocated to this arm receives REBOA in addition to conventional ACLS according to the 2020 AHA CPR guidelines. The common femoral artery is accessed with ultrasound guidance. A sheath catheter is inserted, followed by a REBOA catheter. The REBOA is ballooned with 20cc of normal saline or until resistance is felt.
干预措施: REBOA (Device)
结局指标
主要结局
Number of Participants Who Achieved ROSC (return of spontaneous circulation)
时间窗: 24 hours
Number of patients who achieves ROSC regardless of sustained time
次要结局
- Number of Participants Who Achieved Sustained ROSC(24 hours)
- Survival to Admission(48 hours)
- Survival to Discharge(30 days)
- Neurological Outcome(1 month, 3 months, 6 months since ROSC)
- Changes in Arterial Blood Pressure(ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.)
研究者
Dong Keon Lee
Associate professor
Seoul National University Hospital