Relationship Between Optimal Laryngeal Mask Airway Cuff Volume and Physical Examination of Head and Neck (RCVPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02502422|
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Device: Classic laryngeal mask airway||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prediction of Optimal Laryngeal Mask Airway Cuff Volume From Parameters of Physical Examination of Head and Neck|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
Classic laryngeal mask airway
Device: Classic laryngeal mask airway
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502422
|Korea, Republic of|
|Korea university anam hospital|
|Seoul, Korea, Republic of, 136705|
|Study Director:||Hye-Won Shin, MD, PhD||Department of anesthesiology and pain medicine, Korea University Anam Hospital|