Two Video Laryngoscopes (Laringocel® and C-MAC®) for First-Attempt Intubation in Adults Undergoing Elective Surgery (LARINGOCOL)

Mario Zamudio

Status: Enrolling

Conditions: Intubation, Endotracheal; Airway Management

Treatments: Device: C-MAC® D-Blade videolaryngoscope; Device: Laringocel® videolaryngoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT07239141

IN29-2025

Details and patient eligibility

About

This study will test two video laryngoscopes that help doctors place a breathing tube during surgery. A breathing tube is needed for people who receive general anesthesia so they can breathe safely. Video laryngoscopes use a small camera to give a better view of the throat and vocal cords, which may help the tube go in on the first try.

The purpose of this research is to find out if a Colombian device called Laringocel® works as well as the widely used international device C-MAC D-Blade® (Karl Storz). If Laringocel® performs similarly, it could be a more affordable option for hospitals with limited resources.

252 adults (126 in each group) who need elective surgery at Alma Máter Hospital de Antioquia (Medellín, Colombia) will take part. Each participant will be randomly assigned, like flipping a coin, to have their breathing tube placed with either Laringocel® or C-MAC D-Blade®. Only trained anesthesiologists will perform the procedure.

The study will look at:

Main goal: how often the tube goes in correctly on the first attempt.

Other goals: overall success within 3 attempts, how well the airway is seen, how long the intubation takes, how satisfied the doctor is with the device, and possible side effects such as sore throat, dental injury, or oral injury.

Participation will not change the usual care people receive during anesthesia. Both devices are already approved for clinical use. Risks are the same as with any standard intubation, and participants will be checked after surgery for any problems.

By comparing these two devices, researchers hope to learn if Laringocel® can provide safe and effective intubation at lower cost, improving access to advanced airway tools.

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older
• Patients scheduled for elective surgery under general anesthesia
• Patients requiring single-lumen orotracheal intubation
• Patients compliant with the anesthetic indication and standard preoperative fasting requirements

Exclusion criteria

• Patients with an anticipated difficult airway (more than two anatomical risk factors for difficult airway)
• Patient refusal to participate in the study via informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

Laringocel

Experimental group

Description:

Participants in this group will undergo orotracheal intubation using the Laringocel videolaryngoscope

Treatment:

Device: Laringocel® videolaryngoscope

C-MAC D-Blade

Active Comparator group

Description:

Participants in this group will undergo orotracheal intubation using the C-MAC D-Blade video laryngoscope (Karl Storz).

Treatment:

Device: C-MAC® D-Blade videolaryngoscope