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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

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ClinicalTrials.gov Identifier: NCT01435239
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
Jeong-Rim LEE, Yonsei University

Brief Summary:
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 or disease Intervention/treatment
Surgical Complications From General Anesthesia Device: The cuff inflation by the resting volume Device: The cuff inflation by the maximum volume

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : September 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. The intra-cuff pressure [ Time Frame: approximately 5 to 10 minutes after insertion of LMA. ]
    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.

  2. The leak volume [ Time Frame: approximately 5 to 10 minutes after insertion of LMA. ]
    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.



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Ages Eligible for Study:   up to 9 Years   (Child)
Sexes Eligible for Study:   All
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

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): NCT01435239


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications:
Responsible Party: Jeong-Rim LEE, Assistant Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01435239     History of Changes
Other Study ID Numbers: 1-2011-0046
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014