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

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566224
• Other study ID #: 11MMHIS107
• Status: Completed
• Phase: N/A
• Start date: June 1, 2011
• Est. completion date: May 31, 2012

Study information

• Verified date: September 2020
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 31, 2012
• Est. primary completion date: May 31, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• Macintosh size 2 blade
intubate with Macintosh size 2 blade
• Macintosh size 3 blade
intubate with Macintosh size 3 blade

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

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. — View Citation

Mellick LB, Edholm T, Corbett SW. Pediatric laryngoscope blade size selection using facial landmarks. Pediatr Emerg Care. 2006 Apr;22(4):226-9. — View Citation

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. — View Citation

Outcome

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