Appropriate Laryngeal Mask Airway Size in Patients With Overweight: A Comparison of the Actual Body Weight and Ideal Body Weight

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843270
• Other study ID #: 1-2013-0004
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: September 25, 2014
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It achieves a reliable airway with a low incidence of major complications and pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the proper size selection by actual body weight. It was recommended a size 3 for 30-70kg, a size 4 for 70-90 kg, and size 5 for > 90 kg. Obesity increases the fat tissue around an upper airway and decreases the pharyngeal cross sectional area. Also it was reported that pharyngeal area was reduced according to the increasing of BMI. Therefore, the aim of this study is to determine which of actual body weight or ideal body weight is proper on the size selection of laryngeal mask airway.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• age 20~70

• body mass index > 25 kg/m2

• patient who needs surgery with laryngeal mask airway

Exclusion Criteria:

• difficult airway

• upper airway infection or disease of airway

• history of gastroesophageal reflux

• history of head and neck surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• actual body weight based size
According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.
• ideal body weight based size
According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal leak pressure	Oropharyngeal leak pressure is measured when the airway pressure becomes the plateau state in condition of gas flow 3 L/min and flow out valve 30 cmH2O.	10mins	No