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

Anesthesia Clinical Trial

— RCVPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502422
• Other study ID #: LMA60
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: February 14, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Classic laryngeal mask airway
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.

Locations

Country	Name	City	State
Korea, Republic of	Korea university anam hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No