Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation

NCT05228288 | Completed

• 1 other identifier: COVALENT
• Study Type: interventional
• Target: 2,855
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endotracheal Intubation

Keywords

anesthesiology; laryngoscopy; video-assisted laryngoscopy; intubation; airway management; patient safety; human factors; conventional laryngoscopy

Outcome Measures

Primary Outcomes (1)

• Successful intubation

  The primary endpoint is the successful intubation at first attempt as a dichotomous (successful/unsuccessful) event. The first attempt begins with the laryngoscope spatula passing the patient's row of teeth. The attempt is considered unsuccessful if a complete retraction of the laryngoscope or the endotracheal tube from the oropharynx is necessary for any reason (need for bag ventilation, change of device, change of patient position, change in the curvature of the stylet, etc.). Maneuvers that can be performed during laryngoscopy, such as BURP (backward, upward, rightward pressure) or reclining the head, which end with successful intubation, count towards the first attempt.

  During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory carbon dioxide [CO2] detection is possible)

Secondary Outcomes (8)

• Parameters regarding the duration of the intervention

  During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible)

• Cormack & Lehane grade

  During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible)

• Intubation success

  During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)

• Influence of the device on human factors during the intervention

  During the period of intubation and maintenance of anesthesia

• Complications: occurrence of one or more of the following

  During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)

Study Arms (3)

CDL

ACTIVE COMPARATOR

Conventional direct laryngoscopy using a Macintosh blade

Procedure: Conventional direct laryngoscopy (CDL)

M-VAL

EXPERIMENTAL

Video assisted laryngoscopy with a Macintosh-shaped blade

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

H-VAL

EXPERIMENTAL

Video assisted laryngoscopy with a hyper-angulated blade

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

Interventions

Conventional direct laryngoscopy (CDL) PROCEDURE

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.

Also known as: conventional direct laryngoscopy, conventional laryngoscopy

CDL

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

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.

Also known as: video assisted laryngoscopy with Macintosh-shaped blade

M-VAL

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

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.

Also known as: video assisted laryngoscopy with hyper-angulated blade

H-VAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• University Hospital, Aachen: collaborator
• University Hospital, Bonn: collaborator

Study Sites (1)

University Hospital Wuerzburg

Würzburg, Germany

Location

Related Publications (2)

• Park SY, Kim SH, Lee AR, Cho SH, Chae WS, Jin HC, Lee JS, Kim YI. Prophylactic effect of dexamethasone in reducing postoperative sore throat. Korean J Anesthesiol. 2010 Jan;58(1):15-9. doi: 10.4097/kjae.2010.58.1.15. Epub 2010 Jan 31.

  PMID: 20498806 BACKGROUND

• Schmid B, Eckert D, Meixner A, Pistner P, Malzahn U, Berberich M, Happel O, Meybohm P, Kranke P. Conventional versus video-assisted laryngoscopy for perioperative endotracheal intubation (COVALENT) - a randomized, controlled multicenter trial. BMC Anesthesiol. 2023 Apr 18;23(1):128. doi: 10.1186/s12871-023-02083-3.

  PMID: 37072702 DERIVED

Related Links

• covalent Website

Study Officials

• Benedikt Schmid, MD, PhD

  Department of Anaesthesiology, Medical Faculty Würzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and data analysts will be blinded regarding the assignment of interventions. The randomization result will be communicated to the care providers non-verbally without revealing the result to the patient. Before data evaluation, the identifying variables will be made illegible. Investigators and care providers carrying out the intervention cannot be blinded due to the nature of the study. In the follow-up period two hours after the end of anesthesia, the outcome survey should be performed, if possible, by an investigator who was not involved in the intervention to ensure blinding. It will be documented whether blinding could be accomplished at this point. Un-blinding of the patient is only intended if an unexpected difficult airway situation occurred and the patient is issued a personal anaesthesia problem card. However, even in such cases, blinding can usually be ensured until after the last study visit.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this randomized, controlled, three-armed parallel group design, multi-center trial, a total of more than 2500 adult patients scheduled for perioperative endotracheal intubation will be randomized. In equally large arms, video-assisted laryngoscopy with a Macintosh-shaped or a hyperangulated blade will be compared to the standard of care (direct laryngoscopy with Macintosh blade).

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 8, 2022
• Study Start: March 28, 2022
• Primary Completion: February 17, 2025
• Study Completion: February 18, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)