Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation

Study Overview
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Brief Summary
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Abstract Background Successful tracheal intubation during general anesthesia requires a direct laryngoscope to retract the tongue and soft tissues of the mouth to achieve a line of sight for the larynx. Generally, Macintosh blade laryngoscopy is used to achieve the tracheal intubation. However, difficulties with the tracheal intubation arise the need to use alternative laryngoscopes that use digital or fiberoptic technology, to improve the larynx visibility. Among these devices, highly curved blade videolaryngoscope uses a curved blade to retract the soft tissues of floor of the mouth and transmits a video image to a screen, achieving better larynx visibility. Also, the decrease of the force in the soft tissues with videolaryngoscope could reduce airway injures. Objectives Our primary objective is to assess whether use of videolaryngoscopy using highly curved blades for tracheal intubation in adults requiring general anesthesia reduces risk of airways injuries compared with Macintosh direct laryngoscopy. Our secondary aim is to assess postoperative satisfaction of the patients, successful intubation at the first attempt, successful global intubation, degree of larynx visibility according to classification Cormack - Lehane and time taken to perform intubation in videolaryngoscopy vs direct laryngoscopy. Finally, we assess the risk of presenting serious adverse event with the use of videolaryngoscopy compared with Macintosh laryngoscopy in hypoxemia, bradycardia and heart arrest.

Official Title
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Airway Injuries After Intubation Using Videolaryngoscopy Highly Curved Blades Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation: a Randomized Controlled Trial

Conditions
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Airway Trauma, Airway Complication of Anesthesia

Intervention / Treatment
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* Device: Video laryngoscopy
* Device: Direct laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age. Scheduled for a procedure or surgery that requires general anesthesia that requires orotracheal intubation. Scheduled for non-cardiac surgery. Elective surgery. Exclusion Criteria: Women in pregnancy. Patient refuses to participate in the study before surgery. Patients with predictors of anticipated difficult airway. Head and neck surgery. Go to Intensive Care Unit with endotracheal intubation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single-center randomized study is performed including non-cardiac surgical patients without predictable risk of difficult mask ventilation or of difficult tracheal intubation. For direct laryngoscopy group, we use a Macintosh blade and for videolaryngoscopy group we use videolaryngoscopy highly curved blade. Induction of anesthesia is performed using myorelaxation with rocuronium. We record each five minute the vital signs in the anesthesia record. The primary outcome is observed injuries in the mucosa of the airway: Erythema, edema, ecchymosis, laceration, excoriation and / or hematoma. Injuries to dental pieces: Partial and / or total loss of tooth integrity, loosening of dental piece, damage to dental and / or aesthetic prosthetic material. Laryngeal lesions: Edema, laceration, excoriation, erythema, ecchymosis and / or bleeding pharyngeal laryngeal mucosa, arytenoid luxation. Post-intubation symptoms: Sore throat, dysphonia and / or aphonia.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct laryngoscopy<br>Intubation with direct laryngoscopy (Conventional Intubation) | Device: Direct laryngoscopy<br>* Intubation with direct laryngoscopy with macintosh blade<br>|
| Experimental: Videolaryngoscopy<br>Intubation with videolaryngoscopy (Assisted video intubation) | Device: Video laryngoscopy<br>* Intubation with videolaryngoscopy with highly curved blade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with an airway injury | Airway injury will be a composite outcome as follow: Injury in the oral cavity or injury in the laryngopharynx. These injuries will be evaluated using a digital camera of the oral cavity (fiber optical camera) in the immediate POP. A patient will be considered positive for the outcome If he/she has at least one of the following findings: Erythema, edema, ecchymosis, laceration, excoriation and / or hematoma in labial, jugal, gingival, lingual mucosa, hard and soft palate; Dental pieces injury: partial and / or total loss of the integrity of the dental piece; Larynx lesions: Edema, laceration, excoriation, erythema, ecchymosis and / or bleeding of pharyngeal laryngeal mucosa. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful intubation at the first attempt | Number of patients with successful intubation at the first attempt. | Immediate postoperative | 
| Global of Successful Intubation | Number of patients with successful intubation regardless of the attempts to achieve it. | Immediate postoperative | 
| Cormack-lehane visualization | Degree of Cormack-lehane visualization in each patient. The degree of Cormack-Lehane visualization will be measured from I to IV in relation to the visible portion of the glottis; Grade I with total visualization and Grade IV without visualization of glottis. | Immediate postoperative | 
| Time to achieve orotracheal intubation | Time measured in seconds to achieve orotracheal intubation in each patient. The time interval is determined from the beginning of laryngoscopy by the anesthesiologist until the verification of tracheal intubation by capnography. | Immediate postoperative | 
| Post-anesthetic satisfaction | Post-anesthetic satisfaction in each patient. The Quality of Recovery scale 40 will be used to determine the degree of patient satisfaction, according to the overall and subglobal score, defined by five dimensions: patient support, comfort, emotional, physical independence and pain (includes anatomical airway site). | Immediate postoperative | 
| Hypoxemia during induction and intubation | Number of patients with hypoxemia during induction and intubation. Hypoxaemia is defined as an oxygen saturation measured with pulse oximetry less than 92%. | Immediate postoperative | 
| Bradycardia during induction and intubation | Number of patients with bradycardia during induction and intubation. Bradycardia is defined as a decrease in heart rate of less than 40 beats / minute. | Immediate postoperative | 
| Cardiac Arrest | Number of patients presenting cardiac arrest. Cardiac arrest is defined as the presence of any malignant rhythm: Ventricular tachycardia, ventricular fibrillation, asystole or pulseless electrical activity plus loss of carotid pulse for more than 10 seconds. | Immediate postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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video laryngoscopy, airway, injury, direct laryngoscopy, intubation, endotracheal