Hospital General de Mèxico Dr. Eduardo Liceaga
Mexico City, Cuauhtemoc, 06920, Mexico
NCT Number: NCT06622538
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Mexico City, Cuauhtemoc, 06920, Mexico
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: After the endotracheal intubation completed
Measurement of orotracheal intubations obtained in the first attempt of videolaryngoscopy with the two videolaryngoscopes, successful orotracheal intubation will be corroborated by capnography. Measured in percentage (%).
Time frame: After the endotracheal intubation completed
Time elapsed from the time the video laryngoscope blade crosses the dental arch until the orotracheal tube is inserted into the trachea, this time will be measured for each video laryngoscope. Measured in seconds (s).
Time frame: After the endotracheal intubation completed
Measurement of visualization of glottic structures using the Cormack Lehane scale in grade I, II, II and IV obtained with both video laryngoscopes. Measured in percentage (%).
Time frame: After the endotracheal intubation completed
Measurement of the visualization of the glottic structures using the POGO (Percentage of Glottic Opening) scale from 0% to 100% obtained with both video laryngoscopes. Measured in percentage (%).
Time frame: After the endotracheal intubation completed
Measurement of the number of esophageal intubations obtained with both video laryngoscopes. Measured in percentage (%)
Time frame: After the endotracheal intubation completed
Measurement of complications (mucosal, lip, oral, pharyngeal and laryngeal injury, total or partial fracture of a tooth and Hypoxemia) that occur with the use of the ORION and King Vision Videolaryngoscopes. Measured in percent (%)
Time frame: After the endotracheal intubation completed
Measurement of the number of video laryngoscopy attempts to successful intubation with both video laryngoscopes. Measurement in percentage (%)
Time frame: After the endotracheal intubation completed
Three videolaryngoscopies with duration of 120 seconds each without achieving orotracheal intubation. The number of intubation failures of both videolaryngoscopes will be measured in percentage (%).
Hospital General de México Dr. Eduardo Liceaga
Other Gov
Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients Without Predictors of a Difficult Airway
Acronym: ORION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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