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Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients

Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01367678
Enrollment
30
Registered
2011-06-07
Start date
2011-05-31
Completion date
2011-08-31
Last updated
2011-08-24

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

Conditions

Airway Morbidity, Complication of Device Insertion, Device Induced Injury, Necrosis, Pressure

Brief summary

In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females. Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa. Insertion success rate and oropharyngeal leak pressure were also measured.

Interventions

DEVICELaryngeal Mask Airway Supreme

Directly measured mucosal pressures

DEVICEi-Gel extraglottic airway device

Directly measured mucosal pressures

Sponsors

Medical University Innsbruck
CollaboratorOTHER
Schulthess Klinik
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA I/II * female * age 19-65 years

Exclusion criteria

* \< 19 years * had a known or predicted difficult airway * a body mass index \> 35 kg m-2, or * were at risk of aspiration

Design outcomes

Primary

MeasureTime frame
pharyngeal mucosal pressureevery 5 minutes during steady state anesthesia

Countries

Austria, Switzerland

Outcome results

None listed

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