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

NCT ID: NCT01320163

Last Updated: 2012-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-07-31

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.

Conditions

Endotracheal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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

supra-glottic airway device

Intervention Type: DEVICE

Laryngeal Mask Airway

supra-glottic airway device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

assisstant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul national university hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

H-1001-019-306

Identifier Type: -

Identifier Source: org_study_id