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Completed

NCT Number: NCT02820792

Non-Crossover Study of the LMA Protector Versus Ambu AuraGain

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

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Key information

Conditions

Airway Morbidity

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulthess Klinik, Zurich, Canton of Zurich, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1 or 2
  • Age 19-65 yr
  • Written informed consent

Exclusion criteria

  • Difficult airway
  • Non fasted
  • BMI > 35

Treatment and study plan

function tests

Procedure

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

LMA ProtectorTM

Device

Ambu AuraGainTM

Device

Primary outcomes

  1. oropharyngeal leak pressure

    Time frame: 5 min

    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).

Secondary outcomes

  1. anatomic position

    Time frame: 5 min

    The anatomic position was assessed by passing a fiberoptic scope through the airway tube stopping 0,5 cm prior to the end of the tube. The airway tube view was scored using an established scoring system.

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study title

A Randomized Non-Crossover Study of the LMA ProtectorTM Versus Ambu Aura GainTM in Adult Patients

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2016
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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