Appropriate Laryngeal Mask Airway Size in Patients With Overweight: A Comparison of the Actual Body Weight and Ideal Body Weight
1 other identifier
interventional
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 30, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 29, 2014
January 1, 2014
10 months
April 23, 2013
September 25, 2014
Conditions
Keywords
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
EXPERIMENTALLMA size based on ideal body weight
actual body weight
EXPERIMENTALLMA size according to actual body weight
Interventions
According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.
According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.
Eligibility Criteria
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
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.
PMID: 26240500DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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