Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320163

Enrollment

108

Registered

2011-03-22

Start date

2011-02-28

Completion date

2011-07-31

Last updated

2012-05-30

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

Conditions

Endotracheal Intubation

Brief summary

This study is designed to determine whether a functional difference exists between the laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received neuromuscular blockade.

Interventions

DEVICEi-gel airway (Intersurgical Ltd., Wokingham, England)

supra-glottic airway device

DEVICELaryngeal Mask Airway

supra-glottic airway device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 9 Years

Healthy volunteers

Inclusion criteria

* ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary

Exclusion criteria

* Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status * upper airway abnormality

Design outcomes

Primary

Measure	Time frame	Description
airway leak pressure	within 5 min of insertion of each device	Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

Countries

South Korea

Outcome results

None listed

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