Clinical trial NCT06622538: Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients: ORION Trial
Official title: Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients Without Predictors of a Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orotracheal Intubation
Videolaryngoscopes (VL)
3D Printing
Anesthesia
Keywords: 3d printing
Orotracheal intubation
videolaryngoscope
ORION
Additive Manufacturing
Lead sponsor: Hospital General de México Dr. Eduardo Liceaga
Sponsor class: OTHER_GOV
First posted: 2024-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in two groups
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age scheduled for elective surgery requiring general anesthesia.
* Patients without predictors of difficult airway.
* Patients with ASA I-II classification.
* Patients with BMI less than 35 kg/mts2.

Exclusion Criteria:

* Pregnant women.
* Patients requiring emergency surgery.
* Patients with chronic obstructive pulmonary disease.
* Patients with a history of chronic ischemic heart disease.
* Patients with a history of asthma.
* Patients who have not signed the informed consent to participate in the study.

Primary outcomes:
measure: Successful first attempt
timeFrame: After the endotracheal intubation completed
Secondary outcomes:
measure: Intubation time
timeFrame: After the endotracheal intubation completed
measure: Laryngeal visualisation measured with the Cormack Lehane scale
timeFrame: After the endotracheal intubation completed
measure: Laryngeal visualisation measured with the POGO scale
timeFrame: After the endotracheal intubation completed
measure: Esophageal intubation
timeFrame: After the endotracheal intubation completed
measure: Complications
timeFrame: After the endotracheal intubation completed
measure: Number of video laryngoscopy attempts
timeFrame: After the endotracheal intubation completed
measure: Intubation failure
timeFrame: After the endotracheal intubation completed
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de Mèxico Dr. Eduardo Liceaga
state: Cuauhtemoc
Study officials:
affiliation: Hospital General de Mèxico Dr. Eduardo Liceaga
name: Juan Fernando Bautista Garcia
role: PRINCIPAL_INVESTIGATOR
References: