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

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.

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Key information

Conditions

Anesthesia

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea university anam hospital

Seoul, 136705, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Classic laryngeal mask airway

Device

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.
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.

Primary outcomes

optimal laryngeal mask airway cuff volume

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

Prediction of Optimal Laryngeal Mask Airway Cuff Volume From Parameters of Physical Examination of Head and Neck

Acronym: RCVPE

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jul 20, 2015
Registry last updated: Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed