Mucosal Pressure of the Laryngeal Mask Airway Supreme Ver... | NCT01367678

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jun 3, 2011

First Submission Date that Met QC Criteria

Jun 6, 2011

First Posted Date

Jun 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2011

Last Update Posted Date

Aug 24, 2011Estimated

Name	Class
Medical University Innsbruck	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laryngeal Mask Airway Supreme	Device	Directly measured mucosal pressures	Laryngeal Mask Airway Supreme

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pharyngeal mucosal pressure		every 5 minutes during steady state anesthesia

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Keller, MD, M.Sc.	Schulthess Klinik	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Innsbruck		Innsbruck	Tyrol	6020	Austria
Christian Keller MD, M.Sc.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms