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

Schulthess Klinik

Status: Completed

Conditions: Device Success Rate; Device Performance

Treatments: Device: i-Gel; Device: ProSeal

Study type: Interventional

Funder types: Other

Identifiers

NCT01425151

Schulthess_Anä_2

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

i-Gel

Active Comparator group

Treatment:

Device: i-Gel

ProSeal

Experimental group

Treatment:

Device: ProSeal