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Completed

NCT Number: NCT06213389

Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy

The aim of this study is to compare the EzVision® videoryngoscope with conventional laryngoscopy using a Macintosh blade in patients with suspected difficult intubation. This study primarily aims to test the hypothesis that laryngoscopy image is better with EzVision® videoryngoscopy compared to direct laryngoscopy. The secondary hypothesis is also to test the view that, compared to direct laryngoscopy, EzVision® videolingoscopy will improve intubation success, reduce intubation attempts, shorten intubation time, facilitate intubation, and cause less additional complications such as bleeding or sore throat.

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Key information

Conditions

Intubation; Difficult or Failed Airway Complication of Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Konya, 42000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 to 65 years old;
  • American Association of Anesthesiologists (ASA) physical condition I-II-III;
  • Elective surgery requiring oral endotracheal intubation for general anesthesia;
  • Compliance with one of the difficult intubation estimation criteria (if more than one)
  • Expected extubation in the operating room

Exclusion criteria

  • Refusal to participate in research;
  • Age <18 and >65
  • ASA IV and above
  • Emergency cases
  • Body Mass Index (BMI) > 40 kg/m2.
  • Pregnancy
  • Cardiac surgery
  • Unexpectedly difficult intubation

Treatment and study plan

EzVision® videolaryngoscopy

Device

Patient will be intubated with EzVision® videolaryngoscopy

Macintosh Blade

Device

Patient will be intubated with Macintosh Blade

Primary outcomes

  1. Glottis viewing

    Time frame: Approximately 1 year

    Glottical viewing will be measured by Modified Cormack Lehane grading. In this scoring system, number 1 indicates the best appearance, while number 4 indicates the worst situation where the glottis is not visible. This measurement have no specific value, but it evaluates glottis opening as visually.

    • Fill view of the glottis 2a. Partial view of the glottis 2b. Arytenoids or posterior part of the vocal cords only visible 3. Only epiglottis visible 4. Neither glottis nor epiglottis visible

Secondary outcomes

  1. Intubation failure

    Time frame: Approximately 1 year

    Intubation failure: It is defined as intubation failure if one of the following occurs:

    • Failure to intubate despite three intubation attempts,
    • Situation that requires replacement of the intubation device,
    • Difficulty with intubation that will stop working at the discretion of the anesthesiologist

  2. Attempted intubation

    Time frame: Approximately 1 year

    Attempted intubation: defined as inserting the endotracheal tube into the oral cavity to perform endotracheal intubation (Wang HE, Garza AG)

  3. Intubation time

    Time frame: Approximately 1 year

    Intubation time: defined as the time between insertion of the laryngoscope into the oral cavity and the first appearance of end-tidal CO2.

    Ease of intubation: defined as the anesthetist's subjective assessment after finishing the intubation procedure as: (1) very easy; (2) easy; (3) medium; (4) difficult; and (5) impossible. (Ruetzler K) to.

  4. Ease of intubation

    Time frame: Approximately 1 year

    Ease of intubation: defined as the anesthetist's subjective assessment after finishing the intubation procedure as: (1) very easy; (2) easy; (3) medium; (4) difficult; and (5) impossible. (Ruetzler K)

Sponsors and collaborators

Lead sponsor

Nevsehir Public Hospital

Other Gov

Registry information

Official study title

Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy in Patients Considering Difficult Intubation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2024
Registry last updated
Nov 22, 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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