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

NCT02502422 | Completed DMC

• 1 other identifier: LMA60
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

• optimal laryngeal mask airway cuff volume

  ◦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.

  20minutes

Study Arms (1)

Classic laryngeal mask airway

OTHER

single arm

Device: Classic laryngeal mask airway

Interventions

Classic laryngeal mask airway DEVICE

1. measurement of head and neck * Ht,Wt,BMI, neck circumference above a thyroid cartilage, mandible circumference( from the lower part of earlobe-mandible angle-mentum-mandible angle to the lower part of earlobe), neck length (mastoid tip\~sternal notch), modified mallampati classification under sitting position, thyromental distance. 2. laryngeal mask airway insertion and measuring cuff pressure by pressure transducer * \# 4.0 for female, #5.0 for male * initial cuff volume(air) : maximum volume recommended by the manufacturer * check pressure : if it exceed 60cmH20, we will remove air until 60cmH20 * remove air until gas leak occured around the cuff under airway pressure 15cmH20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured.

Classic laryngeal mask airway

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea university anam hospital

Seoul, 136705, South Korea

Location

Study Officials

• Hye-Won Shin, MD, PhD

  Department of anesthesiology and pain medicine, Korea University Anam Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MD, PhD

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 20, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

KR (1)