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The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Adult Patients

This study is currently recruiting participants.
Verified May 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01606956
First received: May 22, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in adult patients. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.


Condition Intervention
General Anesthesia
 Procedure: The cuff inflation by the resting volume
Procedure: The cuff inflation by half the maximum volume

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Official Title: The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Adult Patients

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The intra-cuff pressure [ Time Frame: approximately 5 to 10 minutes after insertion of LMA. ] [ Designated as safety issue: No ]
    After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer.


Secondary Outcome Measures:
  • leak volume [ Time Frame: approximately 5 to 10 minutes after insertion of LMA. ] [ Designated as safety issue: No ]
    After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume.


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resting volume group Procedure: The cuff inflation by the resting volume
80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
Active Comparator: half the maximum volume group Procedure: The cuff inflation by half the maximum volume
80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients (20-70 years of age) scheduled for elective surgery undergoing general anesthesia using LMA-classic size 3-5

Exclusion Criteria:

  • patients with an abnormal airway,
  • patients with reactive airway disease,
  • patients with gastroesophageal reflux disease,
  • patients with chronic respiratory disease,
  • or a history of an upper respiratory tract infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606956

Contacts
Contact: Jeong Rim Lee, MD 82-2-2228-3840 MANYA@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jeong Rim Lee, MD     82-2-2228-3840     MANYA@yuhs.ac    
Principal Investigator: Jeong Rim Lee, MD            
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01606956     History of Changes
Other Study ID Numbers: 1-2012-0012
Study First Received: May 22, 2012
Last Updated: May 23, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on June 18, 2013