The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01738854
First received: November 22, 2012
Last updated: April 6, 2014
Last verified: April 2014
  Purpose

The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.


Condition Intervention
General Anesthesia
Procedure: intracuff pressure by cuff pressure manometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The oropharyngeal leak pressure volume [ Time Frame: approximately 5 minutes after adjusting intracuff pressure ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intra-cuff pressure 40 cmH2O Procedure: intracuff pressure by cuff pressure manometer
36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.
Active Comparator: intra-cuff pressure 60 cmH2O Procedure: intracuff pressure by cuff pressure manometer
36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.
Active Comparator: intra-cuff pressure 80 cmH2O Procedure: intracuff pressure by cuff pressure manometer
36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.

  Eligibility

Ages Eligible for Study:   up to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients (less than 108months of age)
  • scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5

Exclusion Criteria:

  • Patients with an abnormal airway,
  • reactive airway disease,
  • gastroesophageal reflux disease,
  • chronic respiratory disease,
  • a history of an upper respiratory tract infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738854

Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01738854     History of Changes
Other Study ID Numbers: 1-2012-0043
Study First Received: November 22, 2012
Last Updated: April 6, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
laryngeal mask airway supreme
airway sealing
intracuff pressure

ClinicalTrials.gov processed this record on October 19, 2014