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Ambu AuraOnce Versus Ambu AuraGain LM in Children

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02811042
Enrollment
60
Registered
2016-06-23
Start date
2016-07-31
Completion date
2017-03-31
Last updated
2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management

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.

Interventions

DEVICEAmbu AuraOnce

Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia 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).

The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)

Sponsors

University of Salzburg
CollaboratorOTHER
Schulthess Klinik
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* ASA I-II * 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

Design outcomes

Primary

MeasureTime frame
oropharyngeal leak pressure5 min

Secondary

MeasureTime frame
fiberoptic position5 min

Countries

Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026