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

Primary Purpose

General Anesthesia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

actual body weight based size

ideal body weight based size

About this trial

This is an interventional prevention trial for General Anesthesia focused on measuring general anesthesia, body weight, laryngeal mask airway size

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ideal body weight

actual body weight

Arm Description

LMA size based on ideal body weight

LMA size according to actual body weight

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01843270

First Posted

April 23, 2013

Last Updated

September 25, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01843270

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

General Anesthesia

Keywords

general anesthesia, body weight, laryngeal mask airway size

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ideal body weight

Arm Type

Experimental

Arm Description

LMA size based on ideal body weight

Arm Title

actual body weight

Arm Type

Experimental

Arm Description

LMA size according to actual body weight

Intervention Type

Device

Intervention Name(s)

actual body weight based size

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

ideal body weight based size

Intervention Description

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

Primary Outcome Measure Information:

Title

Oropharyngeal leak pressure

Description

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.

Time Frame

10mins

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26240500

Citation

Kim MS, Lee JS, Nam SB, Kang HJ, Kim JE. Randomized Comparison of Actual and Ideal Body Weight for Size Selection of the Laryngeal Mask Airway Classic in Overweight Patients. J Korean Med Sci. 2015 Aug;30(8):1197-202. doi: 10.3346/jkms.2015.30.8.1197. Epub 2015 Jul 15.

Results Reference

derived

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

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