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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videolaryngoscope King Vision | Active Comparator | The King Vision video laryngoscope used in this study has a 45° angulation, with a disposable No. 3 blade and no channel for the orotracheal tube. |
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| Videolaryngoscope ORION | Experimental | The ORION video laryngoscope is designed by additive manufacturing, has the same dimensions as a Macintosh No. 3 blade, with 45° angulation, is biocompatible and reusable when subjected to high-level disinfection with 2% Glutaraldehyde for 40 minutes. It has an endoscopic camera fully covered in the body of the videolaryngoscope of 8 mm diameter with 2 megapixels with a resolution of 1280x720, has a viewing angle of 70°, has 6 LEDS with adjustable intensity and the camera has an anti-fogging system and can be connected to any mobile device with Android operating system through a free application. (AN98 Version 2.2.0). It complies with ISO 7376:2020 standards for orotracheal intubation laryngoscopes because its blade withstands a stiffness of more than 60 Newtons and a resistance of more than 150 Newtons. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orotracheal intubation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful first attempt | 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 (%). | After the endotracheal intubation completed |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation time | 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). | After the endotracheal intubation completed |
| Laryngeal visualisation measured with the Cormack Lehane scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Fernando Bautista Garcia | Hospital General de Mèxico Dr. Eduardo Liceaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Mèxico Dr. Eduardo Liceaga | Mexico City | Cuauhtemoc | 06920 | Mexico |
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Randomization in two groups
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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 (%). |
| After the endotracheal intubation completed |
| Laryngeal visualisation measured with the POGO scale | 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 (%). | After the endotracheal intubation completed |
| Esophageal intubation | Measurement of the number of esophageal intubations obtained with both video laryngoscopes. Measured in percentage (%) | After the endotracheal intubation completed |
| Complications | 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 (%) | After the endotracheal intubation completed |
| Number of video laryngoscopy attempts | Measurement of the number of video laryngoscopy attempts to successful intubation with both video laryngoscopes. Measurement in percentage (%) | After the endotracheal intubation completed |
| Intubation failure | 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 (%). | After the endotracheal intubation completed |