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Completed

NCT Number: NCT01425151

The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients

In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.

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Key information

Conditions

Device Success Rate Device Performance

Age range

18 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Anästhesie und Allgemeine Intensivmedizin, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I and II
  • Age 1.5-6 years

Exclusion criteria

  • known or predicted difficult airway
  • body mass index > 35 kg m-2
  • risk of aspiration

Treatment and study plan

I-gel

Device

Oropharyngeal leak pressure Insertion success

proseal

Device

Oropharyngeal leak pressure Insertion success

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 10 Minutes

Secondary outcomes

  1. Insertion success rate

    Time frame: 1 Minute

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 29, 2011
Registry last updated
Sep 22, 2011

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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