Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation

Endotracheal Intubation Clinical Trial

— COVALENT  

Official title:

Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228288
• Other study ID #: COVALENT
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2023
• Source: Wuerzburg University Hospital
• Contact: Benedikt Schmid, MD, PhD
• Phone: +49 931 201 30309
• Email: schmid_b[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2600
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Würzburg

Sponsors (3)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	University Hospital, Aachen, University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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

External Links

•   covalent Website