Mixed Reality and Head-mounted Display for Central Venous Catheterization
NCT Number: NCT06469034
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Central Venous Catheterization
Interventions: DEVICE: conventional ultrasound|DEVICE: Mixed reality and head-mounted display ultrasound
Sponsor: The Second Hospital of Anhui Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2025-06-30
Locations: Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230601, China

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.

Primary Outcome Measures: 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 Outcome Measures: 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|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|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|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|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|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|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|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|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|Number of attempts of catheterization, number of attempts until successful catheterization, 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., 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, 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., 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., 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., 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, From application of the ultrasound probe to skin to the beginning of puncture