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Ambu® Aura-ITM Versus Ambu Aura GainTM for Fiberoptic Intubation in Children

A Randomised Non Crossover Study Comparing Ambu® Aura-ITM and Ambu® Aura GainTM for Fiberoptic Intubation in Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03411655
Enrollment
60
Registered
2018-01-26
Start date
2018-03-31
Completion date
2018-08-31
Last updated
2018-01-26

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

Conditions

Anesthesia

Brief summary

The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients

Interventions

DEVICEAmbu Aura GainTM

Time and success rate

DEVICEAmbu® Aura-ITM

Time and success rate

Sponsors

Medical University Innsbruck
CollaboratorOTHER
Schulthess Klinik
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Months to 6 Years
Healthy volunteers
No

Inclusion criteria

* ASA I-II * age 1.5 - 6 years * minor surgery * extraglottic airway device

Exclusion criteria

* age (\<18 months, \>6 years) * weight (\<10 kg, \>20 kg) * a known difficult airway * risk of aspiration

Design outcomes

Primary

MeasureTime frameDescription
Fiberoptic intubation5 minutesThe 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)

Contacts

Primary ContactChristian Keller, MD M.Sc.
christian.keller@kws.ch0041 44 3857462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026