Identification of Interscalene Brachial Plexus on Ultrasonography Using a Deep Neural Network

NCT04183972 | Completed DMC

• 1 other identifier: KY2019-502
• Study Type: interventional
• Target: 1,126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to develop and validate an algorithm based on deep neural networks (DNNs) to identify interscalene brachial plexus on ultrasonography automatically.

Conditions

Ultrasound Therapy; Complications

Keywords

peripheral nerve block; ultrasound image; deep neural network; brachial plexus

Outcome Measures

Primary Outcomes (1)

• The distance of the lateral midpoints of the nerve sheath contours

  between model predictions and the ground truth; between nonexpert anesthesiologist predictions and the ground truth

  immediately after the procedure

Secondary Outcomes (2)

• Accuracy, Sensitivity and specificity

  immediately after the procedure

• The percentage of the intersection over union

  immediately after the procedure

Study Arms (1)

Image collecting Group

EXPERIMENTAL

An computer algorithm will be developed and evaluated by these image data.

Procedure: ultrasound examination

Interventions

ultrasound examination PROCEDURE

the participants will be placed in the supine position, with head turned slightly away from the operating side and arms beside the body. The operator will identify right and left interscalene brachial plexuses by ultrasound equipment (Sonosite EDGE or GE LOGIQ e). Clear images and videos of brachial plexus will be captured and saved.

Image collecting Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status class I or II
• scheduled for elective surgery

You may not qualify if:

• skin lesion or infection of neck
• any known peripheral neuropathy
• brachial nerve plexus injury
• previous injury or operation on neck
• pregnancy
• allergic to ultrasound gel

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

• Yang XY, Wang LT, Li GD, Yu ZK, Li DL, Guan QL, Zhang QR, Guo T, Wang HL, Wang YW. Artificial intelligence using deep neural network learning for automatic location of the interscalene brachial plexus in ultrasound images. Eur J Anaesthesiol. 2022 Sep 1;39(9):758-765. doi: 10.1097/EJA.0000000000001720. Epub 2022 Jul 20.

  PMID: 35919026 DERIVED

Study Officials

• Xiaoyu Yang, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients who have been scheduled to surgery will be recruited for collecting ultrasound images.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 3, 2019
• Study Start: December 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)