NCT01843270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 29, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

April 23, 2013

Last Update Submit

September 25, 2014

Conditions

Keywords

general anesthesiabody weightlaryngeal mask airway size

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

ideal body weight

EXPERIMENTAL

LMA size based on ideal body weight

Device: ideal body weight based size

actual body weight

EXPERIMENTAL

LMA size according to actual body weight

Device: actual body weight based size

Interventions

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

actual body weight

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

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20\~70
  • body mass index \> 25 kg/m2
  • patient who needs surgery with laryngeal mask airway

You may not qualify if:

  • difficult airway
  • upper airway infection or disease of airway
  • history of gastroesophageal reflux
  • history of head and neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 30, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 29, 2014

Record last verified: 2014-01

Locations