External Compression of the Abdominal Aorta to Reduce Femoral Arterial Flow: Comparison Between the Manual Technique and the New Echo-guided Technique
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of the flow reduction for each compression technique
研究概览
简要总结
The aim of this study is to evaluate the efficacy on healthy subjects of Point of Care ultrasonographically guided external aortic compression compared to the manual technique already described.
详细描述
Manual Proximal External Aortic Compression (M-PEAC) has been described for temporizing non-compressible hemorrhage. Point of Care Ultrasonographically guided External Aortic Compression (POCUS-PEAC), a new technique, has been used for management of junctional hemorrhage. The aim of this study is to compare the efficacy of US-PEAC to M-PEAC in reducing the distal arterial flow. This study also evaluates whether a small weight operator would benefit most of the US-PEAC compared to a standard weight operator. Other objectives are to evaluate pain and secondary effects. We will conduct an experimental crossover trial on healthy volunteers. Subjects will be recruited using a convenient sample. M-EAC and US-EAC will be performed on each subject. Femoral arterial flows will be measured by Doppler before and after each compression. Femoral flow reduction will be calculated for each technique and compared. The compression will be first accomplished by an 80 kg operator followed by a 57 kg operator. After each compression, pain will be evaluated using a visual analog scale (VAS). Fifteen minutes after the intervention, pain will be recorded using the same VAS. A follow-up will be ensured at 24 hours and at one week to evaluate for secondary effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 to 40 years old
排除标准
- •<18 years old, >40 years old, BMI <18 or >25, History of abdominal surgery, history of vascular surgery, known aortic disease, known peripheral vascular disease, coronary disease, smoking, history of smoking, diabetes, dislipidemia, arterial hypertension, abdominal or inguinal hernia, eating in the last 4 hours before intervention, abdominal pain on the day of intervention, abdominal bloating on the day of intervention, pregnancy, impossibility to visualize the aorta with the ultrasound
结局指标
主要结局
Comparison of the flow reduction for each compression technique
时间窗: 20 seconds
For each subject, a nurse working at the vascular laboratory will measure the femoral arterial flow using Doppler ultrasound. A measurement will be noted before the interventions, after 20 seconds of manual compression, before the second intervention and after 20 seconds of POCUS compression. The reduction of flow will be calculated for each compression technique and the difference of reduction will be compared. The difference in flow reduction will also be compared for the small weight operator. The two operators will be blinded to the results.
次要结局
- Subject pain evaluation(15 minutes)
- Side effects(7 days)
研究者
Raoul Daoust
Dr
Hopital du Sacre-Coeur de Montreal