Head-mounted Display for Central Venous Catheterization

The Second Hospital of Anhui Medical University

Status: Completed

Conditions: Central Venous Catheterization

Treatments: Device: Head-mounted display ultrasound; Device: conventional ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06469034

YX2024-066(F1)

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Control group

Other group

Description:

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.

Treatment:

Device: conventional ultrasound

HMD group

Experimental group

Description:

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.

Treatment:

Device: Head-mounted display ultrasound