Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation
NCT ID: NCT03613103
Last Updated: 2023-12-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
716 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-10-01
Study Completion Date
2023-12-01
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.
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
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Conditions
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Airway Trauma
Airway Complication of Anesthesia
Keywords
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video laryngoscopy
airway
injury
direct laryngoscopy
intubation
endotracheal
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
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.
A person external to the research group will be responsible for concealment of allocation through opaque and sealed envelopes, listed sequentially.
Study Groups
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Direct laryngoscopy
Intubation with direct laryngoscopy (Conventional Intubation)
Group Type
ACTIVE_COMPARATOR
Direct laryngoscopy
Intervention Type
DEVICE
Intubation with direct laryngoscopy with macintosh blade
Videolaryngoscopy
Intubation with videolaryngoscopy (Assisted video intubation)
Group Type
EXPERIMENTAL
Video laryngoscopy
Intervention Type
DEVICE
Intubation with videolaryngoscopy with highly curved blade
Interventions
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Video laryngoscopy
Intubation with videolaryngoscopy with highly curved blade
Intervention Type
DEVICE
Direct laryngoscopy
Intubation with direct laryngoscopy with macintosh blade
Intervention Type
DEVICE
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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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IPS Universitaria-Universidad de Antioquia
UNKNOWN
Sponsor Role
collaborator
Universidad de Antioquia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Universidad de Antioquia
Medellín, Antioquia, Colombia
Site Status
Countries
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Colombia
References
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RESULT
Other Identifiers
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Airway - 001
Identifier Type: -
Identifier Source: org_study_id