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Clinical Trials/NCT02811042
NCT02811042
Unknown
Not Applicable

Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position

Schulthess Klinik2 sites in 2 countries60 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Management
Sponsor
Schulthess Klinik
Enrollment
60
Locations
2
Primary Endpoint
oropharyngeal leak pressure
Last Updated
9 years ago

Overview

Brief Summary

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ChristianKeller

PD Dr. med. M.Sc.

Schulthess Klinik

Eligibility Criteria

Inclusion Criteria

  • age 1 - 16 years
  • minor surgery
  • extraglottic airway device

Exclusion Criteria

  • age (\<12 months, \>16 years)
  • weight (\<12 kg, \>50 kg)
  • a known difficult airway
  • risk of aspiration

Outcomes

Primary Outcomes

oropharyngeal leak pressure

Time Frame: 5 min

Secondary Outcomes

  • fiberoptic position(5 min)

Study Sites (2)

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