NCT05228288

Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,855 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

COVALENT is a randomized, controlled, multi-center study that aims to evaluate the clinical routine practice of endotracheal intubation in an operative setting comparing video-assisted laryngoscopy to direct laryngoscopy.

Detailed description

Data on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small study populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (irrespective of the shape of the blade) is non-inferior to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure.

Conditions

• Endotracheal Intubation

Interventions

Type	Name	Description
PROCEDURE	Conventional direct laryngoscopy (CDL)	This procedure is considered the gold standard for endotracheal intubation and is routinely used in the peri-operative setting as well as in intensive care and emergency medicine.
PROCEDURE	Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL)	This device is implemented in most german hospitals and used when conventional direct laryngoscopy is not sufficient. By positioning the camera at the tip of the blade, the achievable field of view onto the glottic plane is improved.
PROCEDURE	Video assisted laryngoscopy with hyper-angulated blade (H-VAL)	The hyper-angulated blades are often used as a backup instrument when a view of the glottic plane cannot be achieved with the Macintosh blade due to anatomic abnormalities, even with a video-assisted laryngoscope.

Timeline

• Start date: 2022-03-28
• Primary completion: 2025-02-17
• Completion: 2025-02-18
• First posted: 2022-02-08
• Last updated: 2025-04-03

Locations

1 site across 1 country: Germany