Mixed Reality and Head-mounted Display for Central Venous Catheterization

Central Venous Catheterization Clinical Trial

Official title:

Use of Mixed Reality and Head-mounted Display for Ultrasound-guided Central Venous Catheterization in Adults: a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469034
• Other study ID #: YX2024-066(F1)
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: The Second Hospital of Anhui Medical University
• Contact: Yun Wu, MD, PhD
• Phone: 8613865958254
• Email: wuyunanyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mixed reality (MR) and head-mounted displays (HMD) in medical practice are current research topics. The goal of this clinical trial is to learn if MR and HMD would improve the safety and efficacy in ultrasound-guided central venous catheterization. The main questions it aims to answer are: Does MR and HMD reduce the procedure time and increase the catheterization success rate in ultrasound-guided central venous catheterization. Does MR and HMD increase the satisfaction score of operators and patients. Researchers will compare MR and HMD with the conventional ultrasound in central venous catheterization. Operators will receive either MR and HMD or conventional ultrasound machine to guide internal jugular vein catheterization. The procedure time, puncture success rate, complication and satisfactory score will be recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

We will include patients scheduled for elective surgery under general anesthesia who have indication of internal jugular vein catheterization.

Exclusion Criteria:

Patients with a recent history of internal jugular vein puncture, wound, infection, hematomas, nerve injury at the venous cannulation site, peripheral vascular disease, coagulopathy, history of opiate abuse, pre-existing chronic pain, mental or neurological disorders, allergy to local anesthetics or gel, and unstable vital signs, including hypertension, hypotension or arrhythmia, will be excluded from the study

Related Conditions & MeSH terms

• Central Venous Catheterization

Intervention

Device:
• conventional 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.
• Mixed reality and head-mounted display ultrasound
In the MR + 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. The operators randomized into the MR+HMD group will use a MR ultrasound machine. 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	Ultrasound scan time	the time from application of the ultrasound probe to skin to the beginning of puncture	From application of the ultrasound probe to skin to the end of catheterization
Secondary	Venous access time	period between skin penetration by the needle and the first flashback of venous blood	From application of the ultrasound probe to skin to the end of catheterization
Secondary	Duration of needle visible on the ultrasound image	The duration for which the tip of the needle is visible on the ultrasound image	From application of the ultrasound probe to skin to the end of catheterization
Secondary	Number of needle redirections	the number of times the participant withdraws the needle and re-directs it or advances it at a different angle.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	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.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	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.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	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.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	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.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	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.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	Number of attempts of catheterization	number of attempts until successful catheterization	From application of the ultrasound probe to skin to the end of catheterization
Secondary	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.	From application of the ultrasound probe to skin to the catheter removal
Secondary	pain score of procedure	Patient's pain scale score during the internal jugular vein catheterization	From application of the ultrasound probe to skin to the end of catheterization
Secondary	Failure rate of catheterization.	Inability to cannulate the vein in three attempts will be recorded as a failure.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	Satisfaction score of patients	Satisfaction score of patients after receiving the total procedure.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	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.	From application of the ultrasound probe to skin to the end of catheterization
Secondary	The diameter and depth of the internal jugular vein	The diameter and depth of the internal jugular vein in the image	From application of the ultrasound probe to skin to the beginning of puncture