Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation (COVALENT)

Wuerzburg University Hospital

Status: Completed

Conditions: Endotracheal Intubation

Treatments: Procedure: Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL); Procedure: Conventional direct laryngoscopy (CDL); Procedure: Video assisted laryngoscopy with hyper-angulated blade (H-VAL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05228288

COVALENT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,855 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult, legally competent patients
• Scheduled for elective, non-cardiac surgical procedure
• Need for endotracheal intubation as determined during the premedication visit
• Informed consent
• Care providers performing the intubation have at least one year of training in anesthesiology and experience in the use of VAL

Exclusion criteria

• Lack of ability to give consent
• Previous participation in this study
• Pregnancy
• Need for fiberoptic intubation
• Patients scheduled for bariatric surgery
• Any circumstance that will lead the anesthesiologist(s) in charge to believe that random assignment of a laryngoscopy instrument may compromise patient safety during induction of anesthesia

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,855 participants in 3 patient groups

CDL

Active Comparator group

Description:

Conventional direct laryngoscopy using a Macintosh blade

Treatment:

Procedure: Conventional direct laryngoscopy (CDL)

M-VAL

Experimental group

Description:

Video assisted laryngoscopy with a Macintosh-shaped blade

Treatment:

Procedure: Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL)

H-VAL

Experimental group

Description:

Video assisted laryngoscopy with a hyper-angulated blade

Treatment:

Procedure: Video assisted laryngoscopy with hyper-angulated blade (H-VAL)