Relationship Between Optimal Laryngeal Mask Airway Cuff Volume and Physical Examination of Head and Neck

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Classic laryngeal mask airway

• Registration Number: NCT02502422
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway cuff volume and pressure and physical examination of head and neck.

Detailed Description

Overinflation of laryngeal mask airway cuff can induce side effects like hoarseness, vocal cord paralysis, sorethroat. Some study revealed that 60cmH2O of intracuff pressure is maximum pressure which is not increase side effect.

The manufacturer recommends that the cuff is inflated with the minimum volume of air required to provide an effective seal(max volume - size 3, 20 ml; size 4, 30 ml; size 5, 40).

The investigators will measure anatomical structure (neck circumference, neck length, thyroid-mental distance, etc.) which can influence cuff volume and pressure and find correlation between cuff volume and physical figure measured.

Study Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Study Start: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-14
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Adult (age 19-65)
• American Society of Anesthesiology Classification I-III

Exclusion Criteria

• cardiovascular disease, cerebrovascular disease, pulmonary disease
• patient who have operation history for airway
• patient who expected difficult intubation
• patient who have risk of aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Classic laryngeal mask airway	Classic laryngeal mask airway	single arm

Primary Outcome Measures

Name	Time	Method
optimal laryngeal mask airway cuff volume	20minutes	◦The investigators remove air until gas leak occured around the cuff under airway pressure 15cm H20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured.

Trial Locations

Locations (1)

Korea university anam hospital; 🇰🇷 Seoul, Korea, Republic of