Use of Head-mounted Display for Ultrasound-guided Central Venous Catheterization in Adults: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Total catheterization time
研究概览
简要总结
Head-mounted displays (HMD) in medical practice are current research topics. The goal of this clinical trial is to learn if HMD would improve the safety and efficacy in ultrasound-guided central venous catheterization. The main questions it aims to answer are: Does HMD reduce the procedure time and increase the catheterization success rate in ultrasound-guided central venous catheterization. Does HMD increase the satisfaction score of operators and patients. Researchers will compare HMD with the conventional ultrasound in central venous catheterization. Operators will receive either HMD or conventional ultrasound machine to guide internal jugular vein catheterization. The procedure time, puncture success rate, complication and satisfactory score will be recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients scheduled for elective surgery under general anesthesia
- •Patients indicative of internal jugular vein catheterization.
排除标准
- •1. A recent history of internal jugular vein puncture, wound, infection, hematomas, nerve injury at the venous cannulation site;
- •Combined with peripheral vascular disease, coagulopathy;
- •History of opiate abuse;
- •Pre-existing chronic pain, mental or neurological disorders;
- •Allergy to local anesthetics or gel;
- •Unstable vital signs, including hypertension, hypotension or arrhythmia
研究组 & 干预措施
Control group
The operators in the control group will perform the procedure by visualizing the conventional ultrasound images displayed directly on the ultrasound screen. Each operator will perform an internal jugular vein cannulation via the short-axis approach. To standardize the approach, the ultrasound machine will be placed just to the right of the patient and operators will be asked to stand at the head of the patient and perform the procedure on the patient's internal jugular vein. Each operator could determine the height of the surgical table, and the posture during the procedure that will be most familiar to him/her to increase the success rate. Every procedure will be recorded by focusing on the participant's hands and faces.
干预措施: conventional ultrasound (Device)
HMD group
In the HMD group, the ultrasound machine will be located behind the operator to remove the distraction, and the operator will not be allowed to see the ultrasound screen during the procedure. Images from the ultrasound will be transmitted to HMD via a novel connection developed specifically for this purpose. The operator will wear a pair of HMD and perform the procedure by visualizing the ultrasound images displayed on their HMD screen instead of the ultrasound screen. Each operator will perform an internal jugular vein cannulation via the short-axis approach. Every procedure will be recorded by focusing on the participant's hands and faces.
干预措施: Head-mounted display ultrasound (Device)
结局指标
主要结局
Total catheterization time
时间窗: From application of the ultrasound probe to skin to the end of catheterization
The total catheterization time is defined as the period between the probe positioning on the patient's skin and insertion of the catheter, irrespective of the attempt number of the venous catheterization.
次要结局
- Ultrasound scan time(From application of the ultrasound probe to skin to the end of catheterization)
- Venous access time(From application of the ultrasound probe to skin to the end of catheterization)
- Number of needle redirections(From application of the ultrasound probe to skin to the end of catheterization)
- Number of looks at the monitor(From application of the ultrasound probe to skin to the end of catheterization)
- Time spent looking at the patient(From application of the ultrasound probe to skin to the end of catheterization)
- Time spent looking at the monitor(From application of the ultrasound probe to skin to the end of catheterization)
- First-attempt success rate of internal jugular vein cannulation(From application of the ultrasound probe to skin to the end of catheterization)
- The second attempt success rate(From application of the ultrasound probe to skin to the end of catheterization)
- Number of attempts of needle puncture(From application of the ultrasound probe to skin to the end of catheterization)
- The incidence and severity of complications(From application of the ultrasound probe to skin to the catheter removal)
- pain score of procedure(From application of the ultrasound probe to skin to the end of catheterization)
- Failure rate of catheterization.(From application of the ultrasound probe to skin to the end of catheterization)
- Satisfaction score of patients(From application of the ultrasound probe to skin to the end of catheterization)
- Satisfaction score of operators(From application of the ultrasound probe to skin to the end of catheterization)
- The diameter and depth of the internal jugular vein(From application of the ultrasound probe to skin to the beginning of puncture)
- Number of attempts of guidewire insertion(From application of the ultrasound probe to skin to the end of catheterization)
- Number of probe repositioning(From application of the ultrasound probe to skin to the end of catheterization)
- The distance of tip of the needle from central line of vessel(From application of the ultrasound probe to skin to the end of catheterization)
研究者
Yun Wu
Doctor, Anesthesiology, Principal Investigator
The Second Hospital of Anhui Medical University