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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
124
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.
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 MR ultrasound machine 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.
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Total catheterization time
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.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Ultrasound scan time
the time from application of the ultrasound probe to skin to the beginning of puncture
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Venous access time
period between skin penetration by the needle and the first flashback of venous blood
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of needle redirections
the number of times the participant withdraws the needle and re-directs it or advances it at a different angle.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of looks at the monitor
The number of times the participant looks at the monitor (ultrasound monitor or head-mounted display) during the procedure based on assessment of the subject's head and eye position noted on video.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Time spent looking at the patient
The total amount of time the patient is the main focal point of the participant's view based on assessment of the subject's head and eye position noted on video.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Time spent looking at the monitor
The total amount of time the participant spends looking at the ultrasound monitor or the head-mounted display based on assessment of the subject's head and eye position noted on video.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
First-attempt success rate of internal jugular vein cannulation
The rate of first-attempt success of internal jugular vein cannulation. Successful internal jugular vein cannulation is confirmed by an flashback of venous blood from the catheter.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
The second attempt success rate
The rate of second-attempt success of internal jugular vein cannulation. Second-attempt of puncture is defined as the needle withdrawing to the skin and re-puncture.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of attempts of needle puncture
number of attempts until successful needle puncture
Time frame: From application of the ultrasound probe to skin to the end of catheterization
The incidence and severity of complications
The incidence and severity of complications, such as bleeding, hematoma, arrhythmia, nerve injury, arterial puncture, arterial catheterization, failed catheterization, catheter tip malposition, pneumothorax.
Time frame: From application of the ultrasound probe to skin to the catheter removal
pain score of procedure
Patient's pain scale score during the internal jugular vein catheterization
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Failure rate of catheterization.
Inability to cannulate the vein in three attempts will be recorded as a failure.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Satisfaction score of patients
Satisfaction score of patients after receiving the total procedure.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Satisfaction score of operators
The operators' satisfaction will be recorded on a 5-point scale, where 1 = worst; 2 = poor; 3 = acceptable; 4 = good; and 5 = best. The questionnaire includes: degree of physical fatigue; degree of visual fatigue; motion sickness or dizziness; willingness to use the device again and to recommend it to colleagues; the contribution to patient management; how easily information was able to be read.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
The diameter and depth of the internal jugular vein
The diameter and depth of the internal jugular vein in the image
Time frame: From application of the ultrasound probe to skin to the beginning of puncture
Number of attempts of guidewire insertion
number of attempts until successful guidewire insertion
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of probe repositioning
Number of ultrasound probe repositioning
Time frame: 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
The distance of tip of the needle from central line of vessel
Time frame: From application of the ultrasound probe to skin to the end of catheterization
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