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

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ClinicalTrials.gov Identifier: NCT02502422
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Hye-Won Shin, Korea University Anam Hospital

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
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 : August 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Classic laryngeal mask airway
single arm
Device: Classic laryngeal mask airway
  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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Korea, Republic of
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

Responsible Party: Hye-Won Shin, Director, MD, PhD, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02502422     History of Changes
Other Study ID Numbers: LMA60
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hye-Won Shin, Korea University Anam Hospital:
Laryngeal mask airway