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

Ultrasound Imaging of Anatomical Structures Clinical Trial

— PNB  

Official title:

A Pilot Study to Evaluate Anaesthetists' Ultrasound Scanning & Interpretation Performance for Ultrasound-guided Regional Anaesthesia - With & Without the Assistance of an Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05156099
• Other study ID #: IU2021_AG_06
• Status: Completed
• Start date: December 6, 2021
• Est. completion date: December 8, 2022

Study information

• Verified date: March 2023
• Source: IntelligentUltrasound Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ultrasound Imaging of Anatomical Structures

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Intelligent Ultrasound Limited	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
IntelligentUltrasound Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct identification of appropriate block site (at initial assessment and 2 months later)	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]	12 months
Secondary	Time required to scan (at initial assessment and 2 months later)	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]	12 months
Secondary	confidence in identifying an appropriate block site (at initial assessment and 2 months later)	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)]	12 months
Secondary	Correct identification of key structures (at initial assessment and 2 months later)	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]	12 months
Secondary	Expert observer's assessment (at initial assessment and 2 months later)	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)]	12 months
Secondary	Quantify the change in incorrect identification of safety critical anatomical structures (at initial assessment and 2 months later)	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]	12 months