Head-mounted Display for Central Venous Catheterization

NCT06469034 | Completed DMC

• 1 other identifier: YX2024-066(F1)
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Ultrasound scan time

  From application of the ultrasound probe to skin to the end of catheterization

• Venous access time

  From application of the ultrasound probe to skin to the end of catheterization

• Number of needle redirections

  From application of the ultrasound probe to skin to the end of catheterization

• Number of looks at the monitor

  From application of the ultrasound probe to skin to the end of catheterization

• Time spent looking at the patient

  From application of the ultrasound probe to skin to the end of catheterization

Study Arms (2)

Control group

OTHER

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

HMD group

EXPERIMENTAL

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

Interventions

conventional ultrasound DEVICE

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.

Control group

Head-mounted display ultrasound DEVICE

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.

HMD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective surgery under general anesthesia
• Patients indicative of internal jugular vein catheterization.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Study Officials

• Ye Zhang, MD, PhD

  The Second Hospital of Anhui Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5 years after publication

Locations

CN (1)