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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01425151

Enrollment

Registered

2011-08-29

Start date

2010-01-31

Completion date

2011-09-30

Last updated

2011-09-22

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

Conditions

Device Success Rate, Device Performance

Brief summary

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.

Interventions

DEVICEi-Gel

Oropharyngeal leak pressure Insertion success

DEVICEProSeal

Oropharyngeal leak pressure Insertion success

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Months to 6 Years

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

Design outcomes

Primary

Measure	Time frame
Oropharyngeal leak pressure	10 Minutes

Secondary

Measure	Time frame
Insertion success rate	1 Minute

Countries

Austria, Switzerland

Outcome results

None listed

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