Central Venous Catheterization
Conditions
Brief summary
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.
Interventions
DEVICEconventional ultrasound
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.
DEVICEHead-mounted display ultrasound
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.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for elective surgery under general anesthesia 2. Patients indicative of internal jugular vein catheterization.
Exclusion criteria
1\. A recent history of internal jugular vein puncture, wound, infection, hematomas, nerve injury at the venous cannulation site; 2. Combined with peripheral vascular disease, coagulopathy; 3. History of opiate abuse; 4. Pre-existing chronic pain, mental or neurological disorders; 5. Allergy to local anesthetics or gel; 6. Unstable vital signs, including hypertension, hypotension or arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total catheterization time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction score of operators | From application of the ultrasound probe to skin to the end of catheterization | 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. |
| Ultrasound scan time | From application of the ultrasound probe to skin to the end of catheterization | the time from application of the ultrasound probe to skin to the beginning of puncture |
| Venous access time | From application of the ultrasound probe to skin to the end of catheterization | period between skin penetration by the needle and the first flashback of venous blood |
| Number of needle redirections | From application of the ultrasound probe to skin to the end of catheterization | the number of times the participant withdraws the needle and re-directs it or advances it at a different angle. |
| Number of looks at the monitor | From application of the ultrasound probe to skin to the end of catheterization | 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 spent looking at the patient | From application of the ultrasound probe to skin to the end of catheterization | 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 spent looking at the monitor | From application of the ultrasound probe to skin to the end of catheterization | 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. |
| First-attempt success rate of internal jugular vein cannulation | From application of the ultrasound probe to skin to the end of catheterization | 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. |
| The diameter and depth of the internal jugular vein | From application of the ultrasound probe to skin to the beginning of puncture | The diameter and depth of the internal jugular vein in the image |
| Number of attempts of needle puncture | From application of the ultrasound probe to skin to the end of catheterization | number of attempts until successful needle puncture |
| The incidence and severity of complications | From application of the ultrasound probe to skin to the catheter removal | The incidence and severity of complications, such as bleeding, hematoma, arrhythmia, nerve injury, arterial puncture, arterial catheterization, failed catheterization, catheter tip malposition, pneumothorax. |
| pain score of procedure | From application of the ultrasound probe to skin to the end of catheterization | Patient's pain scale score during the internal jugular vein catheterization |
| Failure rate of catheterization. | From application of the ultrasound probe to skin to the end of catheterization | Inability to cannulate the vein in three attempts will be recorded as a failure. |
| Satisfaction score of patients | From application of the ultrasound probe to skin to the end of catheterization | Satisfaction score of patients after receiving the total procedure. |
| Number of attempts of guidewire insertion | From application of the ultrasound probe to skin to the end of catheterization | number of attempts until successful guidewire insertion |
| Number of probe repositioning | From application of the ultrasound probe to skin to the end of catheterization | Number of ultrasound probe repositioning |
| 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 | The distance of tip of the needle from central line of vessel |
| The second attempt success rate | From application of the ultrasound probe to skin to the end of catheterization | 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. |
Countries
China
Outcome results
None listed