NCT06622538

Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients: ORION Trial

Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients Without Predictors of a Difficult Airway

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hospital General de México Dr. Eduardo Liceaga · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the ORION video laryngoscope with the King Vision video laryngoscope for orotracheal intubation in patients without predictors of difficult airway scheduled for elective surgery under general anesthesia.

Detailed description

The video laryngoscope, compared to direct laryngoscopy, provides better visualization of the laryngeal and glottic structures, a higher success rate for intubation on the first attempt, and a lower incidence of complications such as mucosal injury, dental injury, and esophageal intubations. Despite the advantages offered by video laryngoscopy, its use is not widespread in developing countries due to high costs. For this reason, the ORION video laryngoscope was developed as a low-cost, reusable device that can undergo high-level disinfection. It is designed using additive manufacturing and meets the standards for biocompatibility, rigidity, and resistance. Additionally, it has undergone preclinical testing in simulation models where anesthesiologists have approved its use in real clinical scenarios. In this study, patients scheduled for elective surgery under general anesthesia without predictors of difficult airway will be included and randomized to be intubated with either the ORION video laryngoscope or the King Vision video laryngoscope. The study will compare the success of intubation on the first attempt, the time taken for intubation, the level of visualization of the glottic structures, and the associated complications between the two video laryngoscopes.

Conditions

• Orotracheal Intubation
• Videolaryngoscopes (VL)
• 3D Printing
• Anesthesia

Interventions

Type	Name	Description
DEVICE	Orotracheal intubation	Patients who meet the inclusion criteria and sign the informed consent form will be intubated with the ORION or King Vision video laryngoscope according to randomisation.

Timeline

• Start date: 2024-10-01
• Primary completion: 2024-10-15
• Completion: 2024-10-31
• First posted: 2024-10-02
• Last updated: 2025-02-25

Locations

1 site across 1 country: Mexico