NCT05647174

MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

Developing a Magnetic-POCUS-assisted Bronchoscopy in Difficult Endotracheal Intubation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Introduction Endoracheal intubation (ETI) is a crucial but risky procedure, especially among patients with suspected difficult endotracheal intubation (DTI). Bronchoscopy, as an improved technique commonly used in DTI, might encounters the difficulties of visualization. The magnetic point-of-care ultrasound (MGPOCUS) not only provide an novel visualization from outside, but also enable the estimation of relative position and trajectory of bronchoscopy. The study aims to evaluate the efficiency of MGPOCUS assisted bronchoscopy in time taken to the first-attempt success, the first-attempt and overall success of ETI, complications and satisfaction of visualization among patients suspected with DTI. Methods and analysis The current study is a randomized, parallel-group, single-blinded, single-center study. Participants (n=350) will be recruited by primary anesthesiologist and randomized to groups of ETI with bronchoscopy or MGPOCUS assisted bronchoscopy. The primary outcome is time taken to the first-attempt success ETI. Secondary outcomes include procedure time, the first-attempt and overall success, complications and satisfaction of visualization. Cox regression with the Bonferroni correction and the linear mixed regression will be used to analysis the outcomes.

Conditions

• Airway Management

Interventions

Type	Name	Description
PROCEDURE	MGPOCUS-assisted bronchoscope-guided intubation	Application of ultrasound instruments that can detect magnetic signals to determine the position of the magnetised bronchoscopy to guide the direction of its advancement and thus optimise difficult endotracheal intubation.
PROCEDURE	Bronchoscope-guided intubation	Routine bronchoscope- guided intubation.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-12-31
• Completion: 2026-03-01
• First posted: 2022-12-12
• Last updated: 2023-04-04

Locations

1 site across 1 country: China