Use of smart glasses for ultrasound-guided radial arterial catheterisation in obese patients: study protocol for a single-centre randomised clinical trial in China.

Abstract

Ultrasound guidance improves the success rate and efficiency of radial arterial catheterisation (RAC). However, the procedure remains more challenging in obese patients, in whom excess subcutaneous tissue can impair anatomical visualisation. Additionally, frequent head shifts between the procedural site and ultrasound screen usually increase procedural complexity, prolong the procedural time and adversely affect both patient comfort and clinician performance. Smart glasses that project real-time ultrasound images directly into the clinician's field of view offer a potential solution. The study aimed to evaluate whether the use of smart glasses improves the efficiency of ultrasound-guided RAC in obese patients. In this prospective, single-centre, randomised controlled trial, a total of 176 eligible obese patients (body mass index ≥30 kg/m²) requiring RAC for perioperative monitoring will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either the control group, receiving conventional ultrasound-guided RAC, or the smart-glasses group, undergoing ultrasound-guided RAC with real-time image display and needle-tracking assistance via smart glasses. The primary outcome is the first-attempt success rate. Secondary outcomes include the second-attempt success rate, time to successful catheterisation within the first and second attempts, overall procedural time, overall number of arterial catheterisation attempts; ultrasound scanning time, number of probe repositionings and needle redirections; incidence of RAC-related complications, and satisfaction scores of both patients and clinicians. Statistical analyses will be performed using Statistical Package for the Social Sciences (SPSS) and GraphPad Prism. This study will be conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent will be obtained from all participants before enrolment. The study protocol has been reviewed and approved by the Medical Research Ethics Committee of the Second Affiliated Hospital of Anhui Medical University. This study has been prospectively registered at Chinese Clinical Trial Registry. Study results will be disseminated through presentations at scientific conferences and publication in peer-reviewed scientific journals. ChiCTR2500108023.