Anatomy Guidance for Regional Anaesthesia

NCT03647618 | Completed

• 1 other identifier: ML2018_AG_02
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  3 months

Study Arms (5)

Adductor canal

Patients receiving ultrasound-guided regional anaesthesia

Other: Ultrasound

Popliteal

Patients receiving ultrasound-guided regional anaesthesia

Other: Ultrasound

Fascia Iliaca

Patients receiving ultrasound-guided regional anaesthesia

Other: Ultrasound

Rectus sheath

Patients receiving ultrasound-guided regional anaesthesia

Other: Ultrasound

Axillary

Patients receiving ultrasound-guided regional anaesthesia

Other: Ultrasound

Interventions

Ultrasound OTHER

Ultrasound-guided regional anaesthesia

Adductor canal; Axillary; Fascia Iliaca; Popliteal; Rectus sheath

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medaphor Limited: lead

Study Sites (1)

St Woolos Hospital

Newport, Wales, NP20 4SZ, United Kingdom

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: December 20, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: September 25, 2020

Record last verified: 2019-01

Locations

GB (1)