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

Not Applicable

Completed

• Conditions: Intubation;Difficult
• Interventions: Device: Macintosh size 2 blade; Device: Macintosh size 3 blade

• Registration Number: NCT04566224
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06-01
• Primary Completion: 2012-05-31
• Study Completion: 2012-05-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Last Update Submitted: 2020-09-22
• Study First Posted: 2020-09-28
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh 2 group	Macintosh size 2 blade	Using Macintosh size 2 blade for direct laryngoscope intubation according to randomization
Macintosh 3 group	Macintosh size 3 blade	Using Macintosh size 3 blade for direct laryngoscope intubation according to randomization

Primary Outcome Measures

Name	Time	Method
Teeth trauma	0-10 minutes during induction	Any dental damage event related to intubation
Intubation difficulty scale scores	0-10 minutes during induction	Scoring system to assess the difficulty of intubation in each patient
Intubation time	0-10 minutes during induction	Time from laryngoscope insertion to the first adequate lung insufflation
Cormack-Lehane grade	0-10 minutes during induction	Classification of glottis view during intubation
Tissue trauma	0-10 minutes during induction	Any tissue trauma event related to intubation

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan