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NCT01738854 Clinical Trial

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

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01738854
Other study ID # 1-2012-0043
Secondary ID
Status Completed
Phase N/A
First received November 22, 2012
Last updated April 6, 2014
Start date November 2012
Est. completion date July 2013

Study information
Verified date April 2014
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 9 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Zhang L, Seet E, Mehta V, Subramanyam R, Ankichetty SP, Wong DT, Chung F. Oropharyngeal leak pressure with the laryngeal mask airway Supreme™ at different intracuff pressures: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):624-9. doi: 10.1007/s12630-011-9514-6. Epub 2011 Apr 30. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The oropharyngeal leak pressure volume approximately 5 minutes after adjusting intracuff pressure No
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