Ultrasound ImagingNCT03647618
Anatomy Guidance for Regional Anaesthesia
An observational study of Ultrasound Imaging, run by Medaphor Limited at 1 site in United Kingdom.
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.
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.
- Conditions
- Ultrasound Imaging
- 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 group | Role | What they receive |
|---|---|---|
| Adductor canal | Patients receiving ultrasound-guided regional anaesthesia Receives: Other: Ultrasound | |
| Popliteal | Patients receiving ultrasound-guided regional anaesthesia Receives: Other: Ultrasound | |
| Fascia Iliaca | Patients receiving ultrasound-guided regional anaesthesia Receives: Other: Ultrasound | |
| Rectus sheath | Patients receiving ultrasound-guided regional anaesthesia Receives: Other: Ultrasound | |
| Axillary | Patients 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.
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
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.
- First posted27 Aug 2018
- Study start20 Dec 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medaphor Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy Guidance for Regional Anaesthesia
- ClinicalTrials.gov ID
- NCT03647618
- Acronym / sponsor ID
- ML2018_AG_02
- Conditions
- Ultrasound Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Medaphor LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Adductor canal | – | Other: UltrasoundPatients receiving ultrasound-guided regional anaesthesia |
| Popliteal | – | Other: UltrasoundPatients receiving ultrasound-guided regional anaesthesia |
| Fascia Iliaca | – | Other: UltrasoundPatients receiving ultrasound-guided regional anaesthesia |
| Rectus sheath | – | Other: UltrasoundPatients receiving ultrasound-guided regional anaesthesia |
| Axillary | – | Other: UltrasoundPatients receiving ultrasound-guided regional anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Aged <18 years of age;
- Unwilling or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound-guided regional anaesthesia | Other | Adductor canal, Axillary, Fascia Iliaca, Popliteal, Rectus sheath |
Primary outcome
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Ultrasound Imaging
Recruiting
Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening
Breast Cancer, Ultrasound
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Enrolling by invitationObservational study
Advanced Ultrasound Signal Processing of Suspicious Breast Images
Breast Cancer, Breast Cyst
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Not yet recruiting
"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.