Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation
- Conditions
- Endotracheal Intubation
- Interventions
- Procedure: Video assisted laryngoscopy with hyper-angulated blade (H-VAL)Procedure: Conventional direct laryngoscopy (CDL)Procedure: Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL)
- Registration Number
- NCT05228288
- Lead Sponsor
- Wuerzburg University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2855
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description H-VAL Video assisted laryngoscopy with hyper-angulated blade (H-VAL) Video assisted laryngoscopy with a hyper-angulated blade CDL Conventional direct laryngoscopy (CDL) Conventional direct laryngoscopy using a Macintosh blade M-VAL Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL) Video assisted laryngoscopy with a Macintosh-shaped blade
- Primary Outcome Measures
Name Time Method Successful intubation 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) 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.
- Secondary Outcome Measures
Name Time Method 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) Time to intubation and time to glottis view (as announced by the anesthesist)
Influence of the device on human factors during the intervention During the period of intubation and maintenance of anesthesia Mayo High Performance Teamwork Scale, NASA-TLX (National Aeronautics and Space Administration's Task Load Index)
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) 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)
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) Total number of attempts. Number of attempts using the randomized device. Success rate of intubation attempts regarding the respective device.
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) 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).
Need for auxiliary devices or switch of laryngoscopy 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) 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
Post-operative sore throat, coughing or hoarseness End of surgery until two hours after the end of surgery 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.
Relevant vital parameters during the intervention 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) Baseline SpO2 and lowest SpO2
Trial Locations
- Locations (1)
University Hospital Wuerzburg
🇩🇪Würzburg, Germany