Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB

Intelligent Ultrasound

Status: Completed

Conditions: Ultrasound Imaging of Anatomical Structures

Treatments: Device: Ultrasound Scanning; Device: Ultrasound Scanning - 2 months later

Study type: Observational

Funder types: Industry

Identifiers

NCT05156099

IU2021_AG_06

Details and patient eligibility

About

This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom.

Full description

Current National Institute for Health and Care Excellence (NICE) guidance (NICE, 2009) supports the use of ultrasound-guidance for regional anaesthesia (UGRA) procedures as a consensus of clinical opinion agrees that nerve blocks are more successful and safer with ultrasound (US) guidance. Despite this, UGRA remains a difficult technique to master. This study will be used to determine whether ScanNav Anatomy PNB can support the performance of non-expert anaesthetist in UGRA scanning by highlighting key anatomical structures on the US image in real time.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female, at least 18 years of age

2. Able to comprehend and sign the Informed Consent prior to enrolment in the study

3. Available to travel and attend the study day in person in Cardiff, UK

4. Medical professional (currently practicing anaesthetist or similar clinician) who is qualified to perform UGRA

5. Do not self-identify as an expert in the field of UGRA:

   1. Has not completed advanced training or hold a qualification (e.g., EDRA, MSc, MD, PhD) related to UGRA
   2. Does not regularly deliver anaesthesia for 'awake' surgery (excluding central neuraxial techniques)
   3. Does not teach on formal RA courses

Exclusion criteria

1. Aged <18 years of age
2. Unwilling or unable to provide informed consent
3. Expert in UGRA (see definition above)

Trial design

21 participants in 2 patient groups

ScanNav Anatomy PNB unaided

Description:

The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance without the device.

Treatment:

Device: Ultrasound Scanning - 2 months later

Device: Ultrasound Scanning

ScanNav Anatomy PNB-aided

Description:

The participants will be asked to perform clinically relevant tasks on multiple healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance with the device.

Treatment:

Device: Ultrasound Scanning - 2 months later

Device: Ultrasound Scanning