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Completed

NCT Number: NCT04566224

Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial

Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the differences between Macintosh size 3 and 2 blades, we will analysis the data collected from airway and intubation condition.

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Key information

Conditions

Intubation;Difficult

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

About this study

Selection the most appropriate size of laryngoscope blade size could not only increased intubation successful rate at the first time but also decrease the incidence of tissue trauma. Laryngoscope blade used in daily practice is usually Macintosh 3. However, compared with Caucasian people, Asian people are smaller and thinner especially in women. This study aims to confirm that the Macintosh 2 blade is not inferior to size 3 blade in laryngeal view and intubation rate.

Female patients without known difficult airway will be enrolled and allocated into Macintosh blade size 2 and size 3 groups. The age, body weight, body height, Mallampati classification, mouth opening, thyromental distance, neck circumference, intubation time, Cormack-Lehane grade, intubation difficulty scale scores and associated teeth or tissue traumas will be recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • with American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
  • undergo elective surgery
  • receive endotracheal intubation

Exclusion criteria

  • with known difficult airway (i.e. pathology of the neck, upper airway or alimentary tracts)
  • with risks of pulmonary aspiration (i.e. emergent operation, pregnancy or inadequate nil per os)
  • with previous difficult intubation history
  • intubation attempts more than three times
  • patient refusal

Treatment and study plan

Macintosh size 2 blade

Device

intubate with Macintosh size 2 blade

Macintosh size 3 blade

Device

intubate with Macintosh size 3 blade

Primary outcomes

  1. Intubation time

    Time frame: 0-10 minutes during induction

    Time from laryngoscope insertion to the first adequate lung insufflation

  2. Cormack-Lehane grade

    Time frame: 0-10 minutes during induction

    Classification of glottis view during intubation

  3. Intubation difficulty scale scores

    Time frame: 0-10 minutes during induction

    Scoring system to assess the difficulty of intubation in each patient

  4. Tissue trauma

    Time frame: 0-10 minutes during induction

    Any tissue trauma event related to intubation

  5. Teeth trauma

    Time frame: 0-10 minutes during induction

    Any dental damage event related to intubation

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 28, 2020
Registry last updated
Sep 28, 2020

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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