Head-mounted Display for Central Venous Catheterization

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

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 Overview

• Status: Completed
• Conditions: Central Venous Catheterization
• Intervention / Treatment: Device: conventional ultrasound; Device: Head-mounted display ultrasound

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Second Affiliated hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Experimental: 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.	Device: Head-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of attempts of needle puncture	number of attempts until successful needle puncture	From application of the ultrasound probe to skin to the end of catheterization
Number of attempts of guidewire insertion	number of attempts until successful guidewire insertion	From application of the ultrasound probe to skin to the end of catheterization
Number of probe repositioning	Number of ultrasound 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	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

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University
• Investigators: Study Chair: Ye Zhang, MD, PhD, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: YX2024-066(F1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 5 years after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No