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

Not Applicable

Completed

• Conditions: Airway Trauma; Airway Complication of Anesthesia
• Interventions: Device: Direct laryngoscopy; Device: Video laryngoscopy

• Registration Number: NCT03613103
• Lead Sponsor: Universidad de Antioquia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2018-10-01
• Primary Completion: 2023-10-31
• Status Verified: 2023-12
• Study Completion: 2023-12-01
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct laryngoscopy	Direct laryngoscopy	Intubation with direct laryngoscopy (Conventional Intubation)
Videolaryngoscopy	Video laryngoscopy	Intubation with videolaryngoscopy (Assisted video intubation)

Primary Outcome Measures

Name	Time	Method
Number of patients with an airway injury	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Successful intubation at the first attempt	Immediate postoperative	Number of patients with successful intubation at the first attempt.
Hypoxemia during induction and intubation	Immediate postoperative	Number of patients with hypoxemia during induction and intubation. Hypoxaemia is defined as an oxygen saturation measured with pulse oximetry less than 92%.
Global of Successful Intubation	Immediate postoperative	Number of patients with successful intubation regardless of the attempts to achieve it.
Cormack-lehane visualization	Immediate postoperative	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.
Time to achieve orotracheal intubation	Immediate postoperative	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.
Post-anesthetic satisfaction	Immediate postoperative	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).
Bradycardia during induction and intubation	Immediate postoperative	Number of patients with bradycardia during induction and intubation. Bradycardia is defined as a decrease in heart rate of less than 40 beats / minute.
Cardiac Arrest	Immediate postoperative	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.

Trial Locations

Locations (1)

Universidad de Antioquia; 🇨🇴 Medellin, Antioquia, Colombia