Ultrasound-guided Non-invasive Simulation in Anesthesia Residency Training

NCT07385885 | Not Yet Recruiting DMC

• 1 other identifier: KY20250922-KS-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.Does non-invasive simulated needle puncture training improve objective needle tip visibility during ultrasound-guided peripheral nerve block procedures?
2. 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.

Conditions

Ultrasound; Needle; Residency; Anesthesiology; Training; Non-invasive

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Accuracy of the acquired block view(s)

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

• Nerve block procedure time

  procedure time

• Number of needle insertion attempts

  procedure time

• Expert-rated subjective needle tip visibility score

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

• Time to obtain the correct block view

  procedure time

Study Arms (2)

Traditional Method Teaching Group

NO INTERVENTION

Receive standardized theoretical instruction on ultrasound- guided peripheral nerve blocks; Be randomly assigned to conventional ultrasound scanning training;

Non-invasive Simulated Puncture Teaching Group

EXPERIMENTAL

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

Other: Non-invasive Simulated Puncture Teaching Group

Interventions

Non-invasive Simulated Puncture Teaching Group OTHER

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

Non-invasive Simulated Puncture Teaching Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

LiuHan

Nanjin, Jiangsu, 210006, China

Location

Related Publications (6)

• 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.

  PMID: 26695878 RESULT

• 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.

  PMID: 29872360 RESULT

• 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.

  PMID: 28759501 RESULT

• 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.

  PMID: 36088136 RESULT

• 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.

  PMID: 21425515 RESULT

• 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.

  PMID: 23759709 RESULT

Study Officials

• Hongwei Shi

  Nanjing Hospital Affiliated to Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Han

CONTACT

18951670163; han_cold.student@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)