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Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM

NCT02458794 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-07-29

No results posted yet for this study

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.

Conditions

  • Airway Morbidity

Interventions

PROCEDURE

function tests

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

DEVICE

LMA SupremeTM

DEVICE

Ambu-Aura GainTM

Sponsors & Collaborators

  • Krankenhaus Bozen

    collaborator OTHER

  • Schulthess Klinik

    lead OTHER

Principal Investigators

  • Christian Keller, MD MSc · Schulthess Klinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • Italy
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02458794 on ClinicalTrials.gov