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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong-Rim LEE, Yonsei University
ClinicalTrials.gov Identifier:
NCT01435239
First received: September 14, 2011
Last updated: March 4, 2014
Last verified: March 2014

September 14, 2011
March 4, 2014
September 2011
June 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01435239 on ClinicalTrials.gov Archive Site
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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
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Surgical Complications From General Anesthesia
  • 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.
  • 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.
  • Experimental: resting volume group
    Intervention: Device: The cuff inflation by the resting volume
  • Active Comparator: maximum volume group
    Intervention: Device: The cuff inflation by the maximum volume
Wallace CJ, Chambers NA, Erb TO, von Ungern-Sternberg BS. Pressure volume curves of paediatric laryngeal mask airways. Anaesthesia. 2009 May;64(5):527-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
up to 9 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01435239
1-2011-0046
No
Jeong-Rim LEE, Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP