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Ultrasound ImagingNCT03647618

Anatomy Guidance for Regional Anaesthesia

An observational study of Ultrasound Imaging, run by Medaphor Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ultrasound Imaging
What is being tested?
Ultrasound
How many people
151 participants
Where
1 siteUnited Kingdom
Study dates
20 Dec 2018to 31 Mar 2020
Phase
Observational
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

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • St Woolos Hospital

    Newport, Wales, NP20 4SZ

Other trials in United Kingdom

About this study

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.
Read the 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.

Being tested
Ultrasound

What participants receive

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

  • UltrasoundOther

    Ultrasound-guided regional anaesthesia

Study groups in NCT03647618
Study groupRoleWhat they receive
Adductor canalPatients receiving ultrasound-guided regional anaesthesia
Receives: Other: Ultrasound
PoplitealPatients receiving ultrasound-guided regional anaesthesia
Receives: Other: Ultrasound
Fascia IliacaPatients receiving ultrasound-guided regional anaesthesia
Receives: Other: Ultrasound
Rectus sheathPatients receiving ultrasound-guided regional anaesthesia
Receives: Other: Ultrasound
AxillaryPatients receiving ultrasound-guided regional anaesthesia
Receives: Other: Ultrasound

What is being measured

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

  1. Phase 1 Outcome Measures: - Training/Verification •

    Development and verification of models that identify the target structures using a training dataset. Refinement of Phase II endpoint.

    Measured: 3 months

  2. Phase II Validation Outcome Measures - Validation

    • 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)

    Measured: 3 months

Timeline

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

  1. First posted27 Aug 2018
  2. Study start20 Dec 2018
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647618
Sponsor's protocol ID
ML2018_AG_02
Status last verified
Jan 2019
First submitted
23 Aug 2018
Last updated
25 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ultrasound Imaging, run by Medaphor Limited at 1 site in United Kingdom.

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 3 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: finished, as of the sponsor's last update on 25 Sep 2020. 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 United Kingdom. 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?

Phase 1 Outcome Measures: - Training/Verification • (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Sep 2020.

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