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

NCT ID: NCT01367678

Last Updated: 2011-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Laryngeal Mask Airway Supreme

Directly measured mucosal pressures

Group Type: EXPERIMENTAL

Laryngeal Mask Airway Supreme

Intervention Type: DEVICE

Directly measured mucosal pressures

i-Gel

Directly measured mucosal pressures

Group Type: EXPERIMENTAL

i-Gel extraglottic airway device

Intervention Type: DEVICE

Directly measured mucosal pressures

Interventions

Laryngeal Mask Airway Supreme

Directly measured mucosal pressures

Intervention Type: DEVICE

i-Gel extraglottic airway device

Directly measured mucosal pressures

Intervention Type: DEVICE

Other Intervention Names

Supreme; i-Gel

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: collaborator

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

ChristianKeller

MD, M.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Keller, MD, M.Sc.

Role: STUDY_DIRECTOR

Schulthess Klinik

Locations

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Christian Keller MD, M.Sc.

Zurich, , Switzerland

Countries

Austria; Switzerland

Other Identifiers

Schulthess_Anä_1

Identifier Type: -

Identifier Source: org_study_id