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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial

NCT02208349

Respiratory Failure

TERMINATED NA

Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation

NCT03080896

Intubation; Difficult

COMPLETED NA

Does Training on a Virtual Reality Bronchoscopy Simulator Improve Performance of Bronchoscopic Intubation in Patients?

NCT02699242

Endotracheal Intubation

COMPLETED NA

A Comparative Study of Airtraq Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Resident

NCT04386356

Intubation; Difficult or Failed Intubation Complication

UNKNOWN NA

Learning Curves for Airtraq Versus King Vision Laryngoscopes

NCT03464929

Intubation Laryngoscopy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orotracheal Intubation Videolaryngoscopes (VL) 3D Printing Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization in two groups

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Videolaryngoscope King Vision

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.

Group Type ACTIVE_COMPARATOR

Orotracheal intubation

Intervention Type 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 ORION

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.

Group Type EXPERIMENTAL

Orotracheal intubation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Orotracheal intubation

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes