Clinical trial NCT05228288: Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation
Official title: Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Keywords: anesthesiology
laryngoscopy
video-assisted laryngoscopy
intubation
airway management
patient safety
human factors
conventional laryngoscopy
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Aachen
name: University Hospital, Bonn
First posted: 2022-02-08
Enrollment: 2855
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful intubation
timeFrame: 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:
measure: Parameters regarding the duration of the intervention
timeFrame: 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)
measure: Cormack & Lehane grade
timeFrame: 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)
measure: Intubation success
timeFrame: 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)
measure: Influence of the device on human factors during the intervention
timeFrame: During the period of intubation and maintenance of anesthesia
measure: Complications: occurrence of one or more of the following
timeFrame: 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)
measure: Need for auxiliary devices or switch of laryngoscopy device
timeFrame: 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)
measure: Relevant vital parameters during the intervention
timeFrame: 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)
measure: Post-operative sore throat, coughing or hoarseness
timeFrame: End of surgery until two hours after the end of surgery
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Hospital Wuerzburg
Study officials:
affiliation: Department of Anaesthesiology, Medical Faculty Würzburg
name: Benedikt Schmid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.