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Completed

NCT Number: NCT06469034

Head-mounted Display for Central Venous Catheterization

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.

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Key information

Conditions

Central Venous Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Total catheterization time

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    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.

Secondary outcomes

  1. Ultrasound scan time

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    the time from application of the ultrasound probe to skin to the beginning of puncture

  2. Venous access time

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    period between skin penetration by the needle and the first flashback of venous blood

  3. Number of needle redirections

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    the number of times the participant withdraws the needle and re-directs it or advances it at a different angle.

  4. Number of looks at the monitor

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    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.

  5. Time spent looking at the patient

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    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.

  6. Time spent looking at the monitor

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    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.

  7. First-attempt success rate of internal jugular vein cannulation

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    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.

  8. The second attempt success rate

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    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.

  9. Number of attempts of needle puncture

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    number of attempts until successful needle puncture

  10. The incidence and severity of complications

    Time frame: From application of the ultrasound probe to skin to the catheter removal

    The incidence and severity of complications, such as bleeding, hematoma, arrhythmia, nerve injury, arterial puncture, arterial catheterization, failed catheterization, catheter tip malposition, pneumothorax.

  11. pain score of procedure

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    Patient's pain scale score during the internal jugular vein catheterization

  12. Failure rate of catheterization.

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    Inability to cannulate the vein in three attempts will be recorded as a failure.

  13. Satisfaction score of patients

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    Satisfaction score of patients after receiving the total procedure.

  14. Satisfaction score of operators

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    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.

  15. The diameter and depth of the internal jugular vein

    Time frame: From application of the ultrasound probe to skin to the beginning of puncture

    The diameter and depth of the internal jugular vein in the image

  16. Number of attempts of guidewire insertion

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    number of attempts until successful guidewire insertion

  17. Number of probe repositioning

    Time frame: From application of the ultrasound probe to skin to the end of catheterization

    Number of ultrasound probe repositioning

  18. The distance of tip of the needle from central line of vessel

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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