Central Venous CatheterizationNCT06469034
Head-mounted Display for Central Venous Catheterization
A study testing conventional ultrasound and Head-mounted display ultrasound in people with Central Venous Catheterization, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- conventional ultrasound and Head-mounted display ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery under general anesthesia
- Patients indicative of internal jugular vein catheterization.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: 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.
- Conditions
- Central Venous Catheterization
- Being tested
- conventional ultrasound, Head-mounted display ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ultrasoundDevice
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 ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Head-mounted display ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From application of the ultrasound probe to skin to the end of catheterization
Secondary outcomes (18)
Ultrasound scan time
the time from application of the ultrasound probe to skin to the beginning of puncture
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From application of the ultrasound probe to skin to the end of catheterization
Number of attempts of needle puncture
number of attempts until successful needle puncture
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From application of the ultrasound probe to skin to the beginning of puncture
Number of attempts of guidewire insertion
number of attempts until successful guidewire insertion
Measured: From application of the ultrasound probe to skin to the end of catheterization
Number of probe repositioning
Number of ultrasound probe repositioning
Measured: 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
Measured: From application of the ultrasound probe to skin to the end of catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jul 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Wu, The Second Hospital of Anhui Medical University
- Investigators
- Ye Zhang, MD, PhD, Study chair, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469034
- Sponsor's protocol ID
- YX2024-066(F1)
- Status last verified
- May 2025
- First submitted
- 16 Jun 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang Y, Jiang L, Wang F, Liu P, Xue T, Zhang R, Zheng Z, Wang P, Zhang Y, Wu Y. Use of smart glasses for ultrasound-guided central venous catheterization in adults: a randomized clinical trial. J Clin Anesth. 2026 Oct 3;115:112331. doi: 10.1016/j.jclinane.2026.112331. Online ahead of print.
PubMed 42828913
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Head-mounted Display for Ultrasound-guided Central Venous Catheterization in Adults: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06469034
- Acronym / sponsor ID
- YX2024-066(F1)
- Conditions
- Central Venous Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: conventional ultrasoundThe 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. |
| HMD group | Experimental | Device: Head-mounted display ultrasoundIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective surgery under general anesthesia
- Patients indicative of internal jugular vein catheterization.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional ultrasoundThe 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 | Control group |
| Head-mounted display ultrasoundIn 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. | Device | HMD group |
Primary outcome
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.
18 secondary outcomes
Ultrasound scan time
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Venous access time
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of needle redirections
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of looks at the monitor
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Time spent looking at the patient
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Time spent looking at the monitor
Time frame: From application of the ultrasound probe to skin to the end of catheterization
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 second attempt success rate
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of attempts of needle puncture
Time frame: From application of the ultrasound probe to skin to the end of catheterization
The incidence and severity of complications
Time frame: From application of the ultrasound probe to skin to the catheter removal
pain score of procedure
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Failure rate of catheterization.
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Satisfaction score of patients
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Satisfaction score of operators
Time frame: From application of the ultrasound probe to skin to the end of catheterization
The diameter and depth of the internal jugular vein
Time frame: From application of the ultrasound probe to skin to the beginning of puncture
Number of attempts of guidewire insertion
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Number of probe repositioning
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
Time frame: From application of the ultrasound probe to skin to the end of catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42828913Wang Y, Jiang L, Wang F, Liu P, Xue T, Zhang R, Zheng Z, Wang P, Zhang Y, Wu Y. Use of smart glasses for ultrasound-guided central venous catheterization in adults: a randomized clinical trial. J Clin Anesth. 2026 Oct 3;115:112331. doi: 10.1016/j.jclinane.2026.112331. Online ahead of print.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Zhang, MD, PhD study chair
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional ultrasound and Head-mounted display ultrasound in people with Central Venous Catheterization, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total catheterization time (time frame: From application of the ultrasound probe to skin to the end of catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06469034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.