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

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02502422

Collaborator

(none)

170

Enrollment

Location

Arm

Duration (Months)

42.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: Classic laryngeal mask airway	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Classic laryngeal mask airway single arm	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.

Arm

Intervention/Treatment

Other: Classic laryngeal mask airway

single arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea university anam hospital	Seoul		Korea, Republic of	136705

Sponsors and Collaborators

Korea University Anam Hospital

Investigators

Study Director: Hye-Won Shin, MD, PhD, Department of anesthesiology and pain medicine, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hye-Won Shin, Director, MD, PhD, Korea University Anam Hospital

ClinicalTrials.gov Identifier:

NCT02502422

Other Study ID Numbers:

LMA60

First Posted:

Jul 20, 2015

Last Update Posted:

Feb 17, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Hye-Won Shin, Director, MD, PhD, Korea University Anam Hospital

Laryngeal mask airway

Study Results

No Results Posted as of Feb 17, 2016