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

This study is currently recruiting participants.
Verified March 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Jeong-Rim LEE, Yonsei University
ClinicalTrials.gov Identifier:
NCT01435239
First received: September 14, 2011
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. 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
Surgical Complications From General Anesthesia
 Device: The cuff inflation by the resting volume
Device: The cuff inflation by the maximum volume

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

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 ]
    1) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) 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. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.

  • The leak volume [ Time Frame: approximately 5 to 10 minutes after insertion of LMA. ] [ Designated as safety issue: No ]
    1) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) 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. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resting volume group Device: 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: maximum volume group Device: The cuff inflation by 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:   up to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children (0-9 years of age)
  • children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic

Exclusion Criteria:

  • patients with an abnormal airway
  • patients with reactive airway disease
  • patients with gastroesophageal reflux disease
  • patients with chronic respiratory disease
  • patients who has a history of an upper respiratory tract infection in the preceding 6-week period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435239

Contacts
Contact: Jeong-Rim Lee, MD, PhD 2-2227-3840 MANYA@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jeong Rim Lee, MD, PhD     82-2-2227-3840     MANYA@yuhs.ac    
Principal Investigator: Jeong Rim Lee, MD, PhD            
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Jeong-Rim LEE, Assistant Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01435239     History of Changes
Other Study ID Numbers: 1-2011-0046
Study First Received: September 14, 2011
Last Updated: March 20, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013