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

NCT03613103 | Completed DMC

• 1 other identifier: Airway - 001
• Study Type: interventional
• Target: 716
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Trauma; Airway Complication of Anesthesia

Keywords

video laryngoscopy; airway; injury; direct laryngoscopy; intubation; endotracheal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Successful intubation at the first attempt

  Immediate postoperative

• Global of Successful Intubation

  Immediate postoperative

• Cormack-lehane visualization

  Immediate postoperative

• Time to achieve orotracheal intubation

  Immediate postoperative

• Post-anesthetic satisfaction

  Immediate postoperative

Study Arms (2)

Direct laryngoscopy

ACTIVE COMPARATOR

Intubation with direct laryngoscopy (Conventional Intubation)

Device: Direct laryngoscopy

Videolaryngoscopy

EXPERIMENTAL

Intubation with videolaryngoscopy (Assisted video intubation)

Device: Video laryngoscopy

Interventions

Video laryngoscopy DEVICE

Intubation with videolaryngoscopy with highly curved blade

Videolaryngoscopy

Direct laryngoscopy DEVICE

Intubation with direct laryngoscopy with macintosh blade

Direct laryngoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• IPS Universitaria-Universidad de Antioquia: collaborator

Study Sites (1)

Universidad de Antioquia

Medellín, Antioquia, Colombia

Location

Related Publications (34)

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  RESULT

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be assigned at the time of anesthetic induction in the surgery room. The allocation to the direct laryngoscopy group and the video laryngoscopy will be 1: 1 randomly using permuted blocks, generated by a computer operated by an external assistant to the investigation. The size of the blocks will be between 4, 6, and 8. A person external to the research group will be responsible for concealment of allocation through opaque and sealed envelopes, listed sequentially.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 2, 2018
• Study Start: October 1, 2018
• Primary Completion: October 31, 2023
• Study Completion: December 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)