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

• Sponsor: Mackay Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04566224
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation;Difficult	Device: Macintosh size 2 blade; Device: Macintosh size 3 blade	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial
• Actual Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: May 31, 2012
• Actual Study Completion Date: May 31, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Macintosh 2 group Using Macintosh size 2 blade for direct laryngoscope intubation according to randomization	Device: Macintosh size 2 blade; intubate with Macintosh size 2 blade
Active Comparator: Macintosh 3 group Using Macintosh size 3 blade for direct laryngoscope intubation according to randomization	Device: Macintosh size 3 blade; intubate with Macintosh size 3 blade

Outcome Measures

Primary Outcome Measures

1. Intubation time [0-10 minutes during induction]

   Time from laryngoscope insertion to the first adequate lung insufflation

2. Cormack-Lehane grade [0-10 minutes during induction]

   Classification of glottis view during intubation

3. Intubation difficulty scale scores [0-10 minutes during induction]

   Scoring system to assess the difficulty of intubation in each patient

4. Tissue trauma [0-10 minutes during induction]

   Any tissue trauma event related to intubation

5. Teeth trauma [0-10 minutes during induction]

   Any dental damage event related to intubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mackay Memorial Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Mackay Memorial Hospital

Investigators

• Study Director: Nuan-Yen Su, MS, Mackay Memorial hospital, department of anesthesiology, attending physician

Study Documents (Full-Text)

None provided.

More Information

Publications

• Asai T, Matsumoto S, Fujise K, Johmura S, Shingu K. Comparison of two Macintosh laryngoscope blades in 300 patients. Br J Anaesth. 2003 Apr;90(4):457-60.
• Ashfaque M, Mason J, Al-Shaikh B, Adegoke K. A comparison of the Laryngopharyngeal Examination blade and the English Macintosh laryngoscope blade using an intubating manikin: a prospective randomized crossover study. Eur J Anaesthesiol. 2009 Nov;26(11):917-22. doi: 10.1097/EJA.0b013e32832c7848.
• Mellick LB, Edholm T, Corbett SW. Pediatric laryngoscope blade size selection using facial landmarks. Pediatr Emerg Care. 2006 Apr;22(4):226-9.
• Watanabe S, Suga A, Asakura N, Takeshima R, Kimura T, Taguchi N, Kumagai M. Determination of the distance between the laryngoscope blade and the upper incisors during direct laryngoscopy: comparisons of a curved, an angulated straight, and two straight blades. Anesth Analg. 1994 Oct;79(4):638-41.

• Responsible Party: Ying-Chun Lin, attending physician, department of anesthesiology, Mackay Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04566224
• Other Study ID Numbers: 11MMHIS107
• First Posted: Sep 28, 2020
• Last Update Posted: Sep 28, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ying-Chun Lin, attending physician, department of anesthesiology, Mackay Memorial Hospital: Intubation rate; Macintosh blade; Asian women; intubation difficulty scale
• Additional relevant MeSH terms: Pyrithione zinc

Study Results

No Results Posted as of Sep 28, 2020