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Ultrasoundnon-invasiveNCT07385885

Ultrasound-guided Non-invasive Simulation in Anesthesia Residency Training

A study testing Non-invasive Simulated Puncture Teaching Group in people with Ultrasound and Needle, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Study Aim: This trial evaluates if a novel non-invasive, AI-assisted simulation training improves ultrasound-guided needle visualization skills in anesthesia residents. Design: Trainees were randomized into two groups: Intervention: AI-based, non-invasive simulated needle puncture training. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Ultrasound, Needle, Residency
What is being tested?
Non-invasive Simulated Puncture Teaching Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Feb 2026to 30 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • ~Anesthesiology residents participating in the standardized residency training program in the Department of Anesthesiology at Nanjing First Hospital between October 2024 and October 2026.

Who cannot join

  • Residents with prior experience in performing nerve block procedures.
  • Residents currently participating in other teaching or research studies related to nerve blocks.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • LiuHan

    Nanjin, Jiangsu, 210006

Other trials in China

About this study

Official title: Application of Ultrasound-guided Non-invasive Simulated Puncture Technique in Standardized Residency Training in Anesthesiology

Study Aim: This trial evaluates if a novel non-invasive, AI-assisted simulation training improves ultrasound-guided needle visualization skills in anesthesia residents.

Design: Trainees were randomized into two groups:

Read more

Intervention: AI-based, non-invasive simulated needle puncture training. Control: Conventional ultrasound teaching. Key Outcomes: The primary outcome is objective needle tip visibility. Secondary outcomes include anatomical identification, correct view acquisition, operator confidence, and overall scanning performance.

Assessment: Outcomes are measured via blinded expert evaluation and theoretical tests.

The goal of this randomized controlled clinical trial is to determine whether an ultrasound-guided non-invasive simulated needle puncture training technique can improve ultrasound-guided needle visualization skills in anesthesiology residents undergoing standardized residency training. The study is conducted in anesthesiology residents enrolled in a standardized residency training program.

The main questions it aims to answer are:

  1. Does non-invasive simulated needle puncture training improve objective needle tip visibility during ultrasound-guided peripheral nerve block procedures?
  2. Does this training method improve anatomical structure identification, acquisition of correct block views, operator confidence, and overall scanning performance compared with conventional ultrasound teaching? Researchers will compare a non-invasive simulated needle puncture training group with a conventional ultrasound teaching group to see if the simulated training technique leads to superior needle visualization and procedural performance.

Participants will:

Receive standardized theoretical instruction on ultrasound- guided peripheral nerve blocks; Be randomly assigned to either non-invasive simulated needle puncture training using an artificial intelligence-assisted system or conventional ultrasound scanning training; Perform ultrasound scanning and simulated or conventional practice on healthy volunteers; Undergo theoretical examinations and blinded expert assessments of ultrasound scanning performance and needle visualization outcomes.

Read the detailed description
  1. Teaching Implementation Prior to training, a questionnaire survey was used to collect basic information from the trainees. The course content was developed based on the following textbooks: Clinical Anesthesiology (4th Edition) edited by Guo Qulian and Yao Shanglong and published by People's Medical Publishing House; Modern Anesthesiology (4th Edition) edited by Deng Xiaoming et al. and published by People's Medical Publishing House; and Ultrasound-Guided Nerve Block Techniques edited by Wang Aizhong et al. and published by Shanghai Jiao Tong University Press. All participants initially attended a two-hour instructional course led by two teaching instructors. The course covered the techniques of interscalene brachial plexus, rectus sheath, adductor canal, and sciatic nerve blocks at the popliteal level. The content was based on the recent consensus project for basic ultrasound-guided blocks (Plan A) led by the British Association of Regional Anaesthesia, which defined strongly recommended structures for targeted scanning and block views. The specific structures included: Interscalene Brachial Plexus Block: Anterior scalene muscle; C5 nerve root; C6 nerve root; Middle scalene muscle. Rectus Sheath Block: Peritoneum; Rectus abdominis muscle; Anterior layer of the rectus sheath; Posterior layer of the rectus sheath. Adductor Canal Block: Femoral artery; Saphenous nerve; Sartorius muscle. Sciatic Nerve Block at the Popliteal Level: Common peroneal nerve; Tibial nerve. An additional structure, the popliteal artery, was also included in the block view for the popliteal sciatic nerve block. The teaching integrated practical case studies, images, videos, and other multimedia presentations. It focused on training ultrasound operation techniques, the acquisition of ultrasound images of nerves or tissue structures, structure identification, needle insertion methods, and puncture skills. This instruction aimed to establish a consistent scanning approach for each peripheral nerve block to minimize the influence of different scanning techniques on outcome measures. The instructional course also included familiarization with the Needle Trainer and the Sonosite Edge II ultrasound system, allowing participants to become acquainted with the equipment before evaluation. Two healthy volunteers (BMI 18.5-22 kg/m², aged 20-30 years) were recruited for ultrasound scanning practice. Participants in the experimental group used the Needle Trainer to perform non-invasive simulated puncture training for the four nerve blocks on healthy volunteers, utilizing a retractable virtual puncture needle. This training aimed to develop coordination between needle tracking and the ultrasound probe. Real-time ultrasound scanning provided color-highlighted displays of key ultrasound anatomical structures (the aforementioned four nerve blocks have CE/FDA certification). Participants in the control group used the Sonosite Edge II ultrasound system to perform scanning on healthy volunteers. Both groups prioritized hands-on practice, supplemented by instructor guidance. Participants were encouraged to ask questions at any time, with instructors providing real-time feedback, offering suggestions for improvement, and promptly adjusting participants' operation techniques and skills. Each participant received 12 minutes of ultrasound operation training per session. The training period spanned two weeks, followed by one week of clinical rotation. Both groups received equal training duration and identical instructional content.
  2. Teaching Effectiveness Evaluation 2.1 Theoretical Assessment After the training, a theoretical examination was administered to participants from both groups. The exam focused on the identification of ultrasound anatomical structures and consisted of 25 multiple-choice questions. These questions were divided equally (5 questions each) into five sections: ultrasound basics and operation techniques, interscalene brachial plexus block, rectus sheath block, adductor canal block, and sciatic nerve block at the popliteal level. The total score was 100 points.

2.2 Practical Assessment A single expert, who was blinded to participant group allocation and had not been involved in the earlier instruction, assessed all participants. Each participant performed scans for the four nerve blocks on the same healthy volunteer. For each scan, timing (in seconds) began when the ultrasound probe touched the volunteer's skin and ended when the participant declared they had obtained the correct block view. At that moment, the ultrasound image was frozen and the time was recorded. The expert documented whether the obtained block view was correct (Yes/No). A correct block view was defined as one where the frozen image captured all structures identified during the earlier instruction.

Subsequently, the participant was asked to identify each strongly recommended structure for that specific peripheral nerve block on the original, unmodified ultrasound image displayed on the SonoSite machine. The expert recorded whether each structure identification was correct (Yes/No). Finally, for that scan, the expert gave the participant a global rating score for the scan on a scale from 0 (poor) to 10 (excellent).

For the clinical assessment (performing an adductor canal block on a patient), an experienced attending anesthesiologist or above was present to ensure patient safety and manage any emergent situations. The procedure was evaluated on-site by two experts in ultrasound-guided nerve blocks. The time taken for the nerve block procedure (from needle insertion to completion of the block) was recorded. All ultrasound imaging during each procedure was saved on the ultrasound machine's hard drive and transferred to a computer for subsequent analysis. The total procedure time was recorded from needle skin puncture until the needle tip was clearly visualized in the ultrasound image as successfully contacting the target. The number of puncture attempts was also recorded.

Upon completion of the procedure, the experts subjectively scored the visibility of the participant's needle tip on a scale from 1 (not visible) to 5 (very clear). An objective assessment of the dynamic images was performed using the method proposed by Hebard and Hocking [5]. All recorded ultrasound clips were reviewed independently by two blinded researchers using playback software. Clips were played back at slow speeds (1/4, 1/2 speed) and paused when necessary to precisely determine the presence or absence of the needle tip. The researchers measured the absolute time the needle tip was in view during each procedure (time visible) and calculated the percentage of time the needle tip was visible for each procedure (time visible / total procedure time × 100%), which we defined as the "objective needle tip visibility." The primary outcome measure was this needle tip visibility percentage.

Following this, the operator provided a confidence score regarding needle tip localization (1: no confidence at all, 2: slightly confident, 3: moderately confident, 4: quite confident, 5: very confident (able to accurately judge needle tip position)). Patient satisfaction with analgesia 30 minutes after the nerve block was assessed using an NRS score (0: extremely dissatisfied, 10: completely satisfied). The number of puncture attempts was recorded.

Being tested
Non-invasive Simulated Puncture Teaching Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-invasive Simulated Puncture Teaching GroupOther

    Receive standardized theoretical instruction on ultrasound- guided peripheral nerve blocks; Be randomly assigned to non-invasive simulated needle puncture training using an artificial intelligence-assisted system

Study groups in NCT07385885
Study groupRoleWhat they receive
Traditional Method Teaching GroupNo interventionReceive standardized theoretical instruction on ultrasound- guided peripheral nerve blocks; Be randomly assigned to conventional ultrasound scanning training;
Non-invasive Simulated Puncture Teaching GroupExperimentalReceive standardized theoretical instruction on ultrasound- guided peripheral nerve blocks; Be randomly assigned to non-invasive simulated needle puncture training using an artificial intelligence-assisted system
Receives: Other: Non-invasive Simulated Puncture Teaching Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of needle tip visibility

    For each procedure, investigators measured the absolute time during which the needle tip was visible on ultrasound (visible time) and calculated the percentage of needle tip visibility for each procedure (visible time / total procedure time × 100%), which was defined as objective needle tip visibility. The primary outcome measure of the study was the percentage of needle tip visibility.

    Measured: After two weeks of training, followed by one week of clinical rotation

Secondary outcomes (7)
  1. Accuracy of the acquired block view(s)

    The expert assessed the correctness of block view acquisition (yes/no). A correct block view was defined as the presence of all predefined anatomical structures on the frozen ultrasound image.

    Measured: After two weeks of training, followed by one week of clinical rotation

  2. Nerve block procedure time

    Time from needle insertion to completion of the nerve block procedure

    Measured: procedure time

  3. Number of needle insertion attempts

    The number of puncture attempts was recorded

    Measured: procedure time

  4. Expert-rated subjective needle tip visibility score

    Expert(s) subjectively scored the needle tip visibility for each participant on a scale from 1 (invisible) to 5 (perfectly clear).

    Measured: After two weeks of training, followed by one week of clinical rotation

  5. Time to obtain the correct block view

    The time (in seconds) for each scan was measured from the moment the ultrasound probe made contact with the subject's skin until the participant declared that a correct block view had been obtained. At this point, the ultrasound image was frozen and the time was recorded.

    Measured: procedure time

  6. Operator confidence score

    The operator provided a confidence rating (1 = no confidence at all, 2 = slightly confident, 3 = moderately confident, 4 = quite confident, 5 = very confident (able to accurately identify the needle tip position)).

    Measured: After two weeks of training, followed by one week of clinical rotation

  7. Expert global rating score of ultrasound scanning performance

    The overall quality of each scan was rated by an expert on a 0-10 scale (0 = poor, 10 = excellent).

    Measured: After two weeks of training, followed by one week of clinical rotation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion30 Oct 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385885
Sponsor's protocol ID
KY20250922-KS-02
Acronym
non-invasive
Status last verified
Feb 2026
First submitted
26 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Neal JM, Brull R, Horn JL, Liu SS, McCartney CJ, Perlas A, Salinas FV, Tsui BC. The Second American Society of Regional Anesthesia and Pain Medicine Evidence-Based Medicine Assessment of Ultrasound-Guided Regional Anesthesia: Executive Summary. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):181-94. doi: 10.1097/AAP.0000000000000331.

    PubMed 26695878
  • Soffler MI, Hayes MM, Smith CC. Central venous catheterization training: current perspectives on the role of simulation. Adv Med Educ Pract. 2018 May 25;9:395-403. doi: 10.2147/AMEP.S142605. eCollection 2018.

    PubMed 29872360
  • Chen XX, Trivedi V, AlSaflan AA, Todd SC, Tricco AC, McCartney CJL, Boet S. Ultrasound-Guided Regional Anesthesia Simulation Training: A Systematic Review. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):741-750. doi: 10.1097/AAP.0000000000000639.

    PubMed 28759501
  • Bowness JS, Macfarlane AJR, Burckett-St Laurent D, Harris C, Margetts S, Morecroft M, Phillips D, Rees T, Sleep N, Vasalauskaite A, West S, Noble JA, Higham H. Evaluation of the impact of assistive artificial intelligence on ultrasound scanning for regional anaesthesia. Br J Anaesth. 2023 Feb;130(2):226-233. doi: 10.1016/j.bja.2022.07.049. Epub 2022 Sep 8.

    PubMed 36088136
  • Hebard S, Hocking G. Echogenic technology can improve needle visibility during ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):185-9. doi: 10.1097/aap.0b013e31820d4349.

    PubMed 21425515
  • Wiesmann T, Borntrager A, Zoremba M, Neff M, Wulf H, Steinfeldt T. Compound imaging technology and echogenic needle design: effects on needle visibility and tissue imaging. Reg Anesth Pain Med. 2013 Sep-Oct;38(5):452-5. doi: 10.1097/AAP.0b013e31829730d5.

    PubMed 23759709

Questions about this trial

What is this clinical trial studying?

A study testing Non-invasive Simulated Puncture Teaching Group in people with Ultrasound and Needle, run by Nanjing First Hospital, Nanjing 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu Han (18951670163, han_cold.student@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of needle tip visibility (time frame: After two weeks of training, followed by one week of clinical rotation). 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 NCT07385885, which also lists 6 linked publications.

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 4 Feb 2026.

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