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

Schulthess Klinik

Status: Unknown

Conditions: Anesthesia

Treatments: Device: Ambu Aura GainTM; Device: Ambu® Aura-ITM

Study type: Interventional

Funder types: Other

Identifiers

NCT03411655

Schulthess_Anä_13

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Ambu® Aura-ITM

Active Comparator group

Treatment:

Device: Ambu® Aura-ITM

Ambu Aura GainTM

Active Comparator group

Treatment:

Device: Ambu Aura GainTM