Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy vs Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Time to successful completion of RT procedure
研究概览
简要总结
Resuscitative thoracotomy (RT) is a life saving procedure for patients who have suffered cardiac arrest or are at significant risk of cardiac arrest following significant trauma. The procedure is ideally performed by a surgeon, but in some circumstance must be performed by non-surgical specialists such as Emergency Medicine physicians. The purpose of this study was to evaluate the optimal RT technique taught to non-surgical specialists in an educational human cadaver lab. The objective was to compare time to successful completion of two different RT techniques; (1) Left Anterolateral Thoracotomy (LAT) and (2) Modified Clamshell Thoracotomy (MCT). The investigators hypothesized that the non-surgical specialist time to successful completion for the MCT would be shorter than for the LAT.
详细描述
The investigators conducted a randomized crossover trial of two resuscitative thoracotomy techniques performed by Emergency Medicine (EM) physicians using a fresh human cadaver model. The purpose was to identify the ideal technique to be taught to non-surgical specialists in a training lab setting. The two techniques compared were the Left Anterolateral Thoracotomy (LAT), commonly taught to EM physicians in the United States, and the Modified Clamshell Thoracotomy (MCT) taught by London's Air Ambulance. The investigators hypothesized that the non-surgical specialists time to successful completion of the RT would be faster when performing the MCT compared to the LAT.
The investigators conducted this study at a large level 1 trauma center with an Emergency Medicine residency program and recruited Emergency Medicine residents and staff physicians to participate. Participants were trained on the MCT as performed by LAA and reviewed the LAT technique in a standardized fashion. Participants were then randomized to order of intervention, and conducted each procedure on a separate fresh human cadaver. Participants were evaluated on time to successful completion of the procedure, successful completion of procedural steps, and identification of anatomy. Cadaver specimens were examined for iatrogenic injuries. Participants then completed a standardized survey regarding each procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •licensed physician
- •emergency medicine residency trainee or graduate
- •privileged provider at SAMMC
排除标准
- •unwilling to participate
结局指标
主要结局
Time to successful completion of RT procedure
时间窗: During procedure on data collection date
Time participant took to complete a successful RT procedure. Success includes (1) successful delivery of the heart and (2) successful cross-clamp of the descending thoracic aorta. Success determined by general surgeon observer. Time start from command "go" until participant verbalizes delivery of the heart and cross-clamp of the aorta.
次要结局
- Successful delivery of the heart defined as exposure and inspection of all surfaces(During procedure on data collection date)
- Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp(During procedure on data collection date)
- Time to delivery of the heart defined as exposure and inspection of all surfaces(During procedure on data collection date)
- Time to descending thoracic aorta cross clamp defined as 100% occlusion of the descending aorta with a vascular clamp(During procedure on data collection date)
- Occurrence of iatrogenic injuries(During procedure on data collection date)
- Successful identification of anatomy(During procedure on data collection date)
- Subject Questionnaire(During procedure on data collection date)
研究者
Derek J Brown, MD
Emergency Medicine Physician
Brooke Army Medical Center