Clinical Trials Directory

Trials / Completed

CompletedNCT05156099

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
21 (actual)
Sponsor
IntelligentUltrasound Limited · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEUltrasound ScanningThe 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.
DEVICEUltrasound Scanning - 2 months laterThe 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.

Timeline

Start date
2021-12-06
Primary completion
2022-12-08
Completion
2022-12-08
First posted
2021-12-14
Last updated
2023-03-28

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05156099. Inclusion in this directory is not an endorsement.