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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01738854
Enrollment
36
Registered
2012-11-30
Start date
2012-11-30
Completion date
2013-07-31
Last updated
2014-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

laryngeal mask airway supreme, airway sealing, intracuff pressure

Brief 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.

Interventions

PROCEDUREintracuff 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
No minimum to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The oropharyngeal leak pressure volumeapproximately 5 minutes after adjusting intracuff pressure

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026