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

NCT ID: NCT04566224

Last Updated: 2020-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-01

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Intubation;Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Macintosh 2 group

Using Macintosh size 2 blade for direct laryngoscope intubation according to randomization

Group Type EXPERIMENTAL

Macintosh size 2 blade

Intervention Type DEVICE

intubate with Macintosh size 2 blade

Macintosh 3 group

Using Macintosh size 3 blade for direct laryngoscope intubation according to randomization

Group Type ACTIVE_COMPARATOR

Macintosh size 3 blade

Intervention Type DEVICE

intubate with Macintosh size 3 blade

Interventions

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Macintosh size 2 blade

intubate with Macintosh size 2 blade

Intervention Type DEVICE

Macintosh size 3 blade

intubate with Macintosh size 3 blade

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ying-Chun Lin

attending physician, department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuan-Yen Su, MS

Role: STUDY_DIRECTOR

Mackay Memorial hospital, department of anesthesiology, attending physician

Locations

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Mackay Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Mellick LB, Edholm T, Corbett SW. Pediatric laryngoscope blade size selection using facial landmarks. Pediatr Emerg Care. 2006 Apr;22(4):226-9. doi: 10.1097/01.pec.0000210171.17892.7a.

Reference Type BACKGROUND
PMID: 16651910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19593148 (View on PubMed)

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. doi: 10.1093/bja/aeg086.

Reference Type BACKGROUND
PMID: 12644417 (View on PubMed)

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. doi: 10.1213/00000539-199410000-00004.

Reference Type BACKGROUND
PMID: 7943768 (View on PubMed)

Other Identifiers

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11MMHIS107

Identifier Type: -

Identifier Source: org_study_id

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