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

Completed

• Conditions: Ultrasound Imaging of Anatomical Structures
• Interventions: Device: Ultrasound Scanning; Device: Ultrasound Scanning - 2 months later

• Registration Number: NCT05156099
• Lead Sponsor: IntelligentUltrasound Limited

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study Start: 2021-12-06
• Study First Posted: 2021-12-14
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ScanNav Anatomy PNB unaided	Ultrasound Scanning	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.
ScanNav Anatomy PNB-aided	Ultrasound Scanning - 2 months later	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.
ScanNav Anatomy PNB unaided	Ultrasound Scanning - 2 months later	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.
ScanNav Anatomy PNB-aided	Ultrasound Scanning	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.

Primary Outcome Measures

Name	Time	Method
Correct identification of appropriate block site (at initial assessment and 2 months later)	12 months	Quantify the performance change associated with ScanNav Anatomy PNB during UGRA scanning: (for block regions of the upper limb, trunk, and lower limb).; Correct identification of appropriate block site by participant \[expert observer's opinion; Y/N\]

Secondary Outcome Measures

Name	Time	Method
Time required to scan (at initial assessment and 2 months later)	12 months	Quantify the performance change associated with ScanNav Anatomy PNB during UGRA scanning: (for block regions of the upper limb, trunk, and lower limb) Time in seconds required for participant to scan \[to obtain a satisfactory view of an appropriate block site, in the participant's opinion\]
confidence in identifying an appropriate block site (at initial assessment and 2 months later)	12 months	Quantify the performance change associated with ScanNav Anatomy PNB during UGRA scanning: (for block regions of the upper limb, trunk, and lower limb); Participant confidence in identifying an appropriate block site \[0 (no confidence\] - 10 (total confidence)\]
Quantify the change in incorrect identification of safety critical anatomical structures (at initial assessment and 2 months later)	12 months	Quantify the change in incorrect identification of safety critical anatomical structures associated with ScanNav Anatomy PNB during UGRA scanning (for block regions of the upper limb, trunk and lower limb), False positive/negative identification rates for blood vessels, nerves, pleura and peritoneum by participant \[expert observer's opinion of participant judgement; Y/N\]
Expert observer's assessment (at initial assessment and 2 months later)	12 months	Quantify the performance change associated with ScanNav Anatomy PNB during UGRA scanning (for block regions of the upper limb, trunk, and lower limb) Expert observer's assessment of the participant's total scanning performance \[0 (poor) - 10 (excellent)\]
Correct identification of key structures (at initial assessment and 2 months later)	12 months	Quantify the performance change associated with ScanNav Anatomy PNB during UGRA scanning: (for block regions of the upper limb, trunk, and lower limb) Correct identification of key structures (including safety critical) at that block site by participant \[expert observer's opinion; Y/N\]

Trial Locations

Locations (1)

Intelligent Ultrasound Limited; 🇬🇧 Cardiff, Wales, United Kingdom