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

Not Applicable

Completed

• Conditions: Endotracheal Intubation

• Registration Number: NCT01320163
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-22
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-26
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of