NCT01367678

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

3 months

First QC Date

June 3, 2011

Last Update Submit

August 23, 2011

Conditions

Device Induced InjuryNecrosis, PressureComplication of Device InsertionAirway Morbidity

Outcome Measures

Primary Outcomes (1)

  • pharyngeal mucosal pressure

    every 5 minutes during steady state anesthesia

Study Arms (2)

Laryngeal Mask Airway Supreme

EXPERIMENTAL

Directly measured mucosal pressures

Device: Laryngeal Mask Airway Supreme

i-Gel

EXPERIMENTAL

Directly measured mucosal pressures

Device: i-Gel extraglottic airway device

Interventions

Laryngeal Mask Airway SupremeDEVICE

Directly measured mucosal pressures

Also known as: Supreme
Laryngeal Mask Airway Supreme
i-Gel extraglottic airway deviceDEVICE

Directly measured mucosal pressures

Also known as: i-Gel
i-Gel

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Christian Keller MD, M.Sc.

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Necrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Keller, MD, M.Sc.

    Schulthess Klinik

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, M.Sc.

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 7, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 24, 2011

Record last verified: 2011-08

Locations

AU(1)CH(1)