Anatomy Guidance for Regional Anaesthesia

• ClinicalTrials.gov Identifier: NCT03647618
• Recruitment Status: Completed
• First Posted: August 27, 2018
• Last Update Posted: September 25, 2020
• Sponsor: Medaphor Limited
• Information provided by (Responsible Party): Medaphor Limited

Study Description

Brief Summary:

This mutlicentre study at three hospitals in south Wales, UK, will be used to determine if modern machine learning techniques can help the anaesthetist locate the target by highlighting key anatomical features on the ultrasound image in real time.

The study consists of two phases:

The objective of Phase I is to train a computer-aided system to identify target structures in regional anaesthesia when applied in the following categories:

• Adductor canal
• Popliteal
• Fascia Iliaca
• Rectus sheath
• Axillary The objective of Phase II is to estimate the success rate and safety of the computer system being developed.

Condition or disease	Intervention/treatment
Ultrasound Imaging	Other: Ultrasound

Detailed Description:

Use of regional anaesthesia (RA) and peripheral nerve block (PNB) is growing, although general anaesthesia (GA) is still more common in general surgical practice. Around 65% of all procedures amenable to a regional technique currently use GA, and current UK National Institute of Health and Clinical Excellence (NICE) guidance is that all regional anaesthesia should be performed using ultrasound guidance. However, further increases in regional anaesthesia are expected, as there are significant patient and economic benefits. In particular, the per-procedure costs of regional anaesthesia are considerably less than for general anaesthesia.

Although growing, ultrasound-guided regional anaesthesia is difficult to learn and difficult to perform. There are significant hand-eye-coordination issues as the clinician must simultaneously manipulate both the needle and the ultrasound probe in order to guide the needle to the target. In addition, both the needle and target anatomy can be very difficult to see on the ultrasound image.

The investigators believe that a computer-aided system that highlights key anatomical features on the ultrasound image would make this procedure safer for the patients and simpler for the clinician.

Currently, the leading method for automatic image segmentation uses deep learning, for which many thousands of training images are required. There have been several successes in applying these techniques to medical images, including ultrasound. However, it appears that relatively little attention has been given to automatic segmentation of ultrasound images for regional anaesthesia.

The closest reference to our proposed research describe a method to locate the median nerve in ultrasound images of the forearm. There has also been a Kaggle challenge to segment the brachial plexus nerves in the neck. Multiple anatomical regions can also be segmented at the same time. However, none of these studies are directly applicable to clinical use as they deal only with images captured from healthy volunteers. Neither do they consider how these techniques could be used to aid anaesthetists performing regional anaesthesia in the clinic.

The rationale for this study is to determine whether real-time automatic highlighting of key anatomical features can help clinicians perform ultrasound-guided regional anaesthesia.

Medaphor's proposed system for automatic highlighting uses deep learning and requires many thousands of images for the system to learn from. However, machine learning algorithms such as deep-learning are highly dependent on the images used to construct them. In particular, care must be taken to ensure these algorithms are trained using images representative of those the algorithm will encounter when in use.

A key part of regional anaesthesia involves injecting anaesthetic into the space near the relevant nerve. Once introduced, both the needle and anaesthetic can be seen on the ultrasound image. Models trained using non-invasive images recorded from healthy volunteers will not be sufficient. Although non-invasive images from volunteers may contain the key anatomical features, they will not show the needle and anaesthetic.

The simplest option to capture representative images is to select patients who will be having regional anaesthesia and record the image data directly from the ultrasound machine as the procedure is performed. This method of recording is transparent to both clinician and patient, and does not affect the patient's treatment in any way.

In addition, the ultrasound machines used for regional anaesthesia are not connected to PACS and no patient identifiable information is entered into the ultrasound machine. Since the ultrasound image only is recorded, the videos are completely anonymous and cannot be traced back to any individual.

This study is part of a larger research programme and will build and validate a system capable of highlighting the key anatomical features. Once the system is complete, a further study will be conducted to test it in the clinic to determine potential benefits to patients and clinicians.

Study Design

• Study Type: Observational
• Actual Enrollment: 151 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Anatomy Guidance for Regional Anaesthesia
• Actual Study Start Date: December 20, 2018
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: March 31, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Adductor canal; Patients receiving ultrasound-guided regional anaesthesia	Other: Ultrasound; Ultrasound-guided regional anaesthesia
Popliteal; Patients receiving ultrasound-guided regional anaesthesia	Other: Ultrasound; Ultrasound-guided regional anaesthesia
Fascia Iliaca; Patients receiving ultrasound-guided regional anaesthesia	Other: Ultrasound; Ultrasound-guided regional anaesthesia
Rectus sheath; Patients receiving ultrasound-guided regional anaesthesia	Other: Ultrasound; Ultrasound-guided regional anaesthesia
Axillary; Patients receiving ultrasound-guided regional anaesthesia	Other: Ultrasound; Ultrasound-guided regional anaesthesia

Outcome Measures

Primary Outcome Measures :

1. Phase 1 Outcome Measures: - Training/Verification • [ Time Frame: 3 months ]
   Development and verification of models that identify the target structures using a training dataset. Refinement of Phase II endpoint.
2. Phase II Validation Outcome Measures - Validation [ Time Frame: 3 months ]

   • Validation of the models generated in Phase I using a validation dataset including:-

   • Estimation of performance and accuracy (e.g. success/failure of highlighting of target structures, average distance of highlighting from target, time spent highlighting correct structure as a proportion of time target visible)
   • Estimation of safety (e.g. instances where incorrect highlighting deemed unsafe)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Potential study participants will be identified from patients undergoing regional anaesthesia as part of their treatment at the three clinical centres involved, i.e. the Royal Gwent Hospital, Ystrad Mynach Hospital and St Woolos Hospital, Wales, UK.

Criteria

Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Undergoing regional anaesthesia as part of their treatment at the Royal Gwent Hospital, Ystrad Mynach Hospital and St Woolos Hospital, Wales, UK.
3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged <18 years of age;
2. Unwilling or unable to provide informed consent.

Contacts and Locations

Locations

United Kingdom

St Woolos Hospital

Newport, Wales, United Kingdom, NP20 4SZ

Sponsors and Collaborators

Medaphor Limited

More Information

• Responsible Party: Medaphor Limited
• ClinicalTrials.gov Identifier: NCT03647618
• Other Study ID Numbers: ML2018_AG_02
• First Posted: August 27, 2018
• Last Update Posted: September 25, 2020
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No