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NCT Number: NCT03613103

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

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.

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Key information

Conditions

Airway Trauma Airway Complication of Anesthesia Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Antioquia

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video Laryngoscopy

Device

Intubation with videolaryngoscopy with highly curved blade

direct laryngoscopy

Device

Intubation with direct laryngoscopy with macintosh blade

Primary outcomes

  1. Number of patients with an airway injury

    Time frame: 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 outcomes

  1. Successful intubation at the first attempt

    Time frame: Immediate postoperative

    Number of patients with successful intubation at the first attempt.

  2. Global of Successful Intubation

    Time frame: Immediate postoperative

    Number of patients with successful intubation regardless of the attempts to achieve it.

  3. Cormack-lehane visualization

    Time frame: 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.

  4. Time to achieve orotracheal intubation

    Time frame: 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.

  5. Post-anesthetic satisfaction

    Time frame: 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).

  6. Hypoxemia during induction and intubation

    Time frame: 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%.

  7. Bradycardia during induction and intubation

    Time frame: 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.

  8. Cardiac Arrest

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

  • IPS Universitaria-Universidad de Antioquia

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2018
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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