NCT02458794

Brief Summary

The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 20, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

May 20, 2015

Last Update Submit

July 27, 2015

Conditions

Airway Morbidity

Outcome Measures

Primary Outcomes (1)

  • oropharyngeal seal pressure

    Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

    5 minutes

Secondary Outcomes (1)

  • anatomic position

    5 minutes

Study Arms (2)

LMA SupremeTM

ACTIVE COMPARATOR

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Procedure: function testsDevice: LMA SupremeTM

Ambu-Aura GainTM

ACTIVE COMPARATOR

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Procedure: function testsDevice: Ambu-Aura GainTM

Interventions

function testsPROCEDURE

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

Ambu-Aura GainTMLMA SupremeTM
LMA SupremeTMDEVICE
LMA SupremeTM
Ambu-Aura GainTMDEVICE
Ambu-Aura GainTM

Eligibility Criteria

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

You may qualify if:

  • ASA 1 or 2
  • Age 19-65 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 (2)

Zentralkrankenhaus Bozen

Bolzano, 39100, Italy

Location

Schulthess Klinik

Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Platelet Function Tests

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Christian Keller, MD MSc

    Schulthess Klinik

    STUDY CHAIR

Central Study Contacts

Christian Keller, MD MSc

CONTACT

++41443857462christian.keller@kws.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 1, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

CH(1)IT(1)