NCT01575236

Brief Summary

The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

March 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

3 months

First QC Date

March 30, 2012

Last Update Submit

August 6, 2012

Conditions

Adverse Anesthesia Outcome

Outcome Measures

Primary Outcomes (1)

  • efficacy of oropharyngeal seal pressure

    this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O

    5 min

Secondary Outcomes (1)

  • anatomic position

    5 min

Study Arms (2)

Guardian

EXPERIMENTAL

Guardian Laryngeal Mask

Device: Guardian Laryngeal Mask

Supreme

EXPERIMENTAL

Supreme Laryngeal Mask Airway

Device: Supreme Laryngeal Mask Airway

Interventions

Guardian Laryngeal MaskDEVICE

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Also known as: Guardian Laryngeal Mask, Umedaes
Guardian
Supreme Laryngeal Mask AirwayDEVICE

ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion

Also known as: Supreme Laryngeal Mask Airway, LMA Deutschland GmbH
Supreme

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1 or 2
  • Age 18-75 yr
  • Written informed consent

You may not qualify if:

  • Difficult airway
  • Non fasted
  • BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik für Anästhesie

Innsbruck, Tyrol, 6020, Austria

Location

Study Officials

  • Christian Keller, MD MSc

    Anästhesie Schulthess Klinik

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, M.Sc.

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 11, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

AU(1)