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Completed

NCT Number: NCT00626951

Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients

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Key information

Conditions

Paralysis Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

The LMA Supreme is a new extraglottic airway device which brings together features of both the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use - prevention of disease transmission). The new features are that the airway tube incorporates a drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been strengthened to prevent airway obstruction from infolding and epiglottic fins have been added to prevent airway obstruction from epiglottic downfolding. In the following randomized, crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed, anesthetized patients

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiology physical status grade I-II
  • Age 18-80 yr
  • Elective gynecological surgery
  • Supine position

Exclusion criteria

  • Known or predicted difficult airway
  • Body mass index >35 kg m-2
  • Risk of aspiration

Treatment and study plan

LMA Supreme

Device

Extraglottic airway devices

LMA proseal

Device

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 5 min

Secondary outcomes

  1. Ease of insertion

    Time frame: 1 min

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients

Acronym: Supreme

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 29, 2008
Registry last updated
Jul 3, 2008

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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