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Completed

NCT Number: NCT04701762

Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified

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Key information

Conditions

Intubation Laryngoscopy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia.

A cluster randomized multiple crossover design is used for this trial. The cardiac surgical suites will be divided into 2 sets of 11 operating rooms. Each set is treated as a unit and randomized to receive video or direct laryngoscopy in 1-week blocks, always with 1 set randomized to each approach. For analysis, each operating room within a set will be considered a separate cluster. Randomization will be conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators access these codes a day before each new treatment block begins.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.

Exclusion criteria

  • The attending anesthesiologist prefers a specific approach for a particular patient
  • Awake fiberoptic intubation is clinically indicated
  • Insertion of double-lumen tube.

Treatment and study plan

GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)

Device

After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, Washington 98011) is an FDA-cleared commercially available portable videolaryngoscope.

direct laryngoscopy

Device

After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);

Primary outcomes

  1. The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.

    Time frame: From the start time of intubation to time of the end of surgery up to 24 hours.

    Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.

Secondary outcomes

  1. Intubation Failure

    Time frame: From the start time of intubation to time of the end of surgery.

    Intubation failure is defined by the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts.

  2. Any Dental or Airway Injury

    Time frame: From the start time of intubation to time of the end of surgery.

    Airway injury is defined as any bleeding or apparent injury to the lips, mouth, pharynx, vocal cords, or other airway structures recorded by the anesthesia team.

    Dental injury is defined as any apparent injury to the teeth as recorded by the anesthesia team.

Other outcomes

  1. Maximum Mean Arterial Pressure

    Time frame: In five minutes after intubation.

    Maximum mean arterial pressure (MAP) in the five minutes after intubation

  2. Maximum Heart Rate (HR)

    Time frame: In five minutes after intubation

    Maximum heart rate in the five minutes after intubation

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2021
Registry last updated
Sep 19, 2024

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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