Transesophageal Echocardiography in Pre-hospital Cardiac Arrest Patients; TAPCAP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment
研究概览
简要总结
The Use of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in Cardiac Arrest and Acute Coronary Syndrome Patients
Studies have shown that POCUS can rapidly change the management in nearly 80% of cases in emergency settings, particularly in environments such as war zones and disaster relief. TTE is highly sensitive in diagnosing acute coronary syndromes and can effectively rule out myocardial infarction. In cardiac arrest patients, TTE assists in determining cardiac activity and identifying reversible causes, such as pericardial tamponade and pneumothorax. However, TTE can be affected by suboptimal image quality due to factors like chest compression in out-of-hospital cardiac arrest (OHCA) patients.
In Taiwan's emergency medical system, EMT-Ps (paramedics) undergo approximately one year of training, which enables them to provide emergency care, including ultrasound examinations, before hospital arrival. Research on pre-hospital cardiac arrest has shown that most ultrasound applications can be completed within 3 minutes and do not significantly increase on-scene time.
TEE, though advantageous for its high-quality imaging and ability to reduce interruptions during chest compressions, faces challenges in pre-hospital emergency applications due to specialized training and equipment requirements. However, a study in Vienna, Austria, demonstrated that TEE could be performed and yield high-quality images in most pre-hospital cases, with an average examination time of 5.1 minutes.
Several hospitals in Taiwan have begun training personnel in TEE, emphasizing the importance of establishing TEE image registries for large-scale, effective research analysis. However, these efforts also face challenges related to resources and collaboration. The research team has over three years of experience using TEE in the emergency department to examine OHCA patients, and a three-year study will be conducted to validate the efficacy of pre-hospital TEE in cardiac arrest patients.
详细描述
Background:
The application of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in cardiac arrest and acute coronary syndrome has evolved with technological advancements. POCUS, in particular, has been recognized for its ability to change clinical management in nearly 80% of emergency cases, such as war and disaster scenarios. TTE is highly sensitive in diagnosing acute coronary syndromes and can effectively rule out myocardial infarction. It also plays a crucial role in identifying reversible causes in cardiac arrest patients, like pericardial tamponade and pneumothorax, but its image quality can be compromised during chest compressions in out-of-hospital cardiac arrest (OHCA) patients. TEE, on the other hand, offers superior image quality and reduces interruptions during chest compressions but requires specialized training and equipment.
Currently, Taiwan's emergency medical system allows EMT-P personnel, after a year of training, to perform pre-hospital ultrasounds, including POCUS, for OHCA patients. Research has shown that most ultrasound applications can be completed in under 3 minutes without significantly increasing on-scene time. TEE's use in pre-hospital emergencies has also been validated in international studies, such as those from Vienna, which demonstrated TEE's feasibility in providing clear diagnostic images during pre-hospital cardiac arrest care.
Research Methods:
This study aims to assess the feasibility and efficacy of TEE in pre-hospital cardiac arrest care through a randomized controlled trial over three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with out-of-hospital cardiac arrest (OHCA)
- •Non-traumatic cause of cardiac arrest
排除标准
- •Presence of obvious signs of death, such as decapitation, rigor mortis, livor mortis, or decomposition.
- •Family explicitly expresses a Do Not Attempt Resuscitation (DNR) order, or the patient has a documented refusal of resuscitation.
- •Any condition that contraindicates the use of transesophageal echocardiography (TEE), such as esophageal tumors, preventing probe insertion.
- •Patients eligible for ECPR (Extracorporeal Cardiopulmonary Resuscitation) treatment.
- •Spontaneous circulation has already been stabilized before performing TEE.
研究组 & 干预措施
Performing TEE
In this group of patients, transesophageal echocardiography (TEE) will be performed to confirm optimal chest compression positioning while utilizing a mechanical chest compression device.
干预措施: transesophageal echocardiography (Diagnostic Test)
not performing TEE
In this group of patients, transesophageal echocardiography (TEE) will not be performed, and the mechanical chest compression device will be positioned at the intersection of the nipple line and the sternum.
结局指标
主要结局
Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment
时间窗: 30 days after cardiac arrest or upon the patient's death, whichever came first
Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment. The proportion of successfully ensuring LV compression during prehospital CPR.
次要结局
- Sustained return of spontaneous circulation (sustained ROSC) lasting approximately 20 minutes(Patient sustained ROSC for 20 minutes after)
- Time from the start of resuscitation to the first return of spontaneous circulation (ROSC)(1 minute after patient first ROSC)
- Any ROSC rate(1 minute after patient ROSC)
- Favorable neurologic outcome with discharge to home (Cerebral Performance Category 1 or 2)(Up to 6 months after discharge date)
- End-tidal carbon dioxide (EtCO2)(One hour after arriving at the hospital)
研究者
Jen-Tang Sun
Director of Emergency Surgery
Far Eastern Memorial Hospital