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

NCT06622538 | Completed DMC

• 1 other identifier: DI/24/310/03/26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

3d printing; Orotracheal intubation; videolaryngoscope; ORION; Additive Manufacturing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Intubation time

  After the endotracheal intubation completed

• Laryngeal visualisation measured with the Cormack Lehane scale

  After the endotracheal intubation completed

• Laryngeal visualisation measured with the POGO scale

  After the endotracheal intubation completed

• Esophageal intubation

  After the endotracheal intubation completed

• Complications

  After the endotracheal intubation completed

Study Arms (2)

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.

Device: Orotracheal intubation

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.

Device: Orotracheal intubation

Interventions

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.

Videolaryngoscope King Vision; Videolaryngoscope ORION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead

Study Sites (1)

Hospital General de Mèxico Dr. Eduardo Liceaga

Mexico City, Cuauhtemoc, 06920, Mexico

Location

Study Officials

• Juan Fernando Bautista Garcia

  Hospital General de Mèxico Dr. Eduardo Liceaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Randomization in two groups

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 31, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)