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

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.

Study Overview

• Status: Recruiting
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Procedure: Conventional direct laryngoscopy (CDL); Procedure: Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL); Procedure: Video assisted laryngoscopy with hyper-angulated blade (H-VAL)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benedikt Schmid, MD, PhD; Phone Number: +49 931 201 30309; Email: schmid_b@ukw.de
• Study Contact Backup: Name: Peter Kranke, MD, PhD; Phone Number: +49 931 201-30050; Email: kranke_p@ukw.de

Study Locations

• Germany
  • Würzburg, Germany
    • Recruiting
    • University Hospital Wuerzburg
    • Contact: Benedikt Schmid, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CDL; Conventional direct laryngoscopy using a Macintosh blade	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.; Other Names: conventional direct laryngoscopy; conventional laryngoscopy
Experimental: M-VAL; Video assisted laryngoscopy with a Macintosh-shaped blade	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.; Other Names: video assisted laryngoscopy with Macintosh-shaped blade
Experimental: H-VAL; Video assisted laryngoscopy with a hyper-angulated blade	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.; Other Names: video assisted laryngoscopy with hyper-angulated blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters regarding the duration of the intervention	Time to intubation and time to glottis view (as announced by the anesthesist)	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	Grade 1 (full view of glottis), Grade 2a (partial view of glottis), Grade 2b (view only of posterior extremity of glottis or arytenoid cartilages), Grade 3 (view of epiglottis, none of the glottis), Grade 4 (neither view of glottis nor epiglottis)	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	Total number of attempts. Number of attempts using the randomized device. Success rate of intubation attempts regarding the respective device.	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	Mayo High Performance Teamwork Scale, NASA-TLX (National Aeronautics and Space Administration's Task Load Index)	During the period of intubation and maintenance of anesthesia
Complications: occurrence of one or more of the following	Drop of SpO2 (oxygen saturation) below 90%. Regurgitation as announced by the anesthetist. Need for bronchoscopy due to suspected aspiration. Dental injury or dental clicks upon contact with the blade. Soft tissue injuries as detected by blood on the blade. Visible swelling. Bleeding or other injury of the lips. Need for resuscitation (administration of adrenalin, chest compressions, defibrillation or any combination thereof). Death. Occurence of any adverse event (AE) or serious adverse event (SAE).	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)
Need for auxiliary devices or switch of laryngoscopy device	Manœuvres to optimize intubation conditions after the first attempt at intubation has started. Switch to alternate laryngoscopy device. Switch of the anesthetists. Switch of airway device	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)
Relevant vital parameters during the intervention	Baseline SpO2 and lowest SpO2	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)
Post-operative sore throat, coughing or hoarseness	Post-operative sore throat, coughing or hoarseness, according to the "Scoring System for Sore Throat, Cough, and Hoarseness" by Park et al. This outcome will not be assessed in patients who continue to be invasively ventilated > 2 hours after surgery.	End of surgery until two hours after the end of surgery

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: University Hospital, Bonn; University Hospital, Aachen
• Investigators: Principal Investigator: Benedikt Schmid, MD, PhD, Department of Anaesthesiology, Medical Faculty Würzburg

Publications and helpful links

General Publications

• 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.

Helpful Links

• covalent Website

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: airway management; intubation; patient safety; laryngoscopy; anesthesiology; human factors; video-assisted laryngoscopy; conventional laryngoscopy
• Additional Relevant MeSH Terms: Dermatologic Agents; Keratolytic Agents; Pyrithione zinc
• Other Study ID Numbers: COVALENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No