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NCT Number: NCT05850052

McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation

The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

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Key information

Conditions

Surgery

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital,, Istanbul, Turkey (Türkiye)

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About this study

The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective surgery requiring oral endotracheal intubation for general anesthesia;
  • Anticipated extubation in the operating room;
  • American Society of Anesthesiologists (ASA) physical status 2-3;
  • Age between 18 and 99 years;
  • Body Mass index ≥ 40 kg/m2.

Exclusion criteria

  • Refusal of participation by attending anesthesiologist;
  • Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
  • Indicated fiberoptic awake intubation.

Treatment and study plan

McGrath videolaryngoscope for rapid sequence endotracheal intubation

Device

Visualize a patient's airway to aid placement of tracheal tube with ease.

Conventional direct laryngoscopy using a Macintosh blade

Device

Examine a patient's airway to aid placement of tracheal tube with ease.

Primary outcomes

  1. Visualization of the Vocal Cords

    Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.

    The visualization of the vocal cords, defined using the modified Cormack and Lehane classification:

    Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible).

    Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen).

    Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen).

Secondary outcomes

  1. Number of Participants With 1, 2, 3, and 4 Intubation Attempts

    Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.

    An intubation attempt was recorded once the endotracheal tube entered the oral cavity

  2. Intubation Failure.

    Time frame: From the start time of intubation to time of the end of surgery, up to 12 hours.

    Intubation was considered a failure if there was: (1) a failure to intubate after 3 attempts, (2) the need to switch intubators or intubation device, or (3) the need to stop study per anesthesiologist's discretion.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Comparison of Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Rapid Sequence Intubation: an International, Multicenter Randomized Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 9, 2023
Registry last updated
Feb 3, 2025

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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