Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622538
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients ORION Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients Without Predictors of a Difficult Airway
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORION
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None