Developing a magnetic POCUS-guided bronchoscope for patients with suspected difficult endotracheal intubation in a general tertiary hospital: protocol for a randomised controlled study

INTRODUCTION: Endotracheal intubation (ETI) is a crucial but risky procedure, especially among patients suspected of difficult endotracheal intubation (DTI). Bronchoscope, as an improved technique commonly used in DTI, might encounter visualisation difficulties. The magnetic point-of-care ultrasound (MGPOCUS) provides a novel visualisation from the outside and enables estimation of the relative position and trajectory of the bronchoscope. The purpose of the study was to evaluate the efficiency of MGPOCUS-guided bronchoscopy, including the time required for successful ETI, the first attempt and overall success rate, the number of attempts, complications, and satisfaction with the visualization of the procedures. METHODS AND ANALYSIS: The study is a randomised, parallel-group, single-blinded, single-centre study. Participants (n=108) will be recruited by the primary anaesthesiologist and randomised to groups of ETI with bronchoscope or MGPOCUS-guided bronchoscope. The primary outcome is the time taken to the first-attempt success ETI. Secondary outcomes include procedure time, the first-attempt and overall success, complications, and satisfaction of visualisation. Cox regression with Bonferroni correction and linear mixed regression will be used to analyse the outcomes. ETHICS AND DISSEMINATION: The trial protocol was approved by the ethics committees at the Peking Union Medical College Hospital (Institutional Review Board #ZS-3428). Findings will be disseminated through conference presentations and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05647174