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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Laryngeal Mask Airway Supreme

i-Gel extraglottic airway device

About this trial

This is an interventional basic science trial for Device Induced Injury

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Medical University Innsbruck
Christian Keller MD, M.Sc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Laryngeal Mask Airway Supreme

i-Gel

Arm Description

Directly measured mucosal pressures

Outcomes

Primary Outcome Measures

pharyngeal mucosal pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT01367678

First Posted

June 3, 2011

Last Updated

August 23, 2011

Sponsor

Schulthess Klinik

Collaborators

Medical University Innsbruck

1. Study Identification

Unique Protocol Identification Number

NCT01367678

Brief Title

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

Official Title

Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Schulthess Klinik

Collaborators

Medical University Innsbruck

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laryngeal Mask Airway Supreme

Arm Type

Experimental

Arm Description

Directly measured mucosal pressures

Arm Title

i-Gel

Arm Type

Experimental

Arm Description

Directly measured mucosal pressures

Intervention Type

Device

Intervention Name(s)

Laryngeal Mask Airway Supreme

Other Intervention Name(s)

Supreme

Intervention Description

Directly measured mucosal pressures

Intervention Type

Device

Intervention Name(s)

i-Gel extraglottic airway device

Other Intervention Name(s)

i-Gel

Intervention Description

Directly measured mucosal pressures

Primary Outcome Measure Information:

Title

pharyngeal mucosal pressure

Time Frame

every 5 minutes during steady state anesthesia

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Keller, MD, M.Sc.

Organizational Affiliation

Schulthess Klinik

Official's Role

Study Director

Facility Information:

Facility Name

Medical University Innsbruck

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Christian Keller MD, M.Sc.

City

Zürich

ZIP/Postal Code

8008

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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