Clinical trial NCT03613103: Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation
Official title: Airway Injuries After Intubation Using Videolaryngoscopy Highly Curved Blades Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Trauma
Airway Complication of Anesthesia
Keywords: video laryngoscopy
airway
injury
direct laryngoscopy
intubation
endotracheal
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: IPS Universitaria-Universidad de Antioquia
First posted: 2018-08-02
Enrollment: 716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with an airway injury
timeFrame: 24 hours
Secondary outcomes:
measure: Successful intubation at the first attempt
timeFrame: Immediate postoperative
measure: Global of Successful Intubation
timeFrame: Immediate postoperative
measure: Cormack-lehane visualization
timeFrame: Immediate postoperative
measure: Time to achieve orotracheal intubation
timeFrame: Immediate postoperative
measure: Post-anesthetic satisfaction
timeFrame: Immediate postoperative
measure: Hypoxemia during induction and intubation
timeFrame: Immediate postoperative
measure: Bradycardia during induction and intubation
timeFrame: Immediate postoperative
measure: Cardiac Arrest
timeFrame: Immediate postoperative
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Universidad de Antioquia
state: Antioquia
Study officials:
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