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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01320163
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Duration (Months): 4.9
• Patients Per Site Per Month: 21.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endotracheal Intubation	Device: i-gel airway (Intersurgical Ltd., Wokingham, England); Device: Laryngeal Mask Airway	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul national university hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin-Tae Kim, assisstant professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01320163
• Other Study ID Numbers: H-1001-019-306
• First Posted: Mar 22, 2011
• Last Update Posted: May 30, 2012
• Last Verified: May 1, 2012

Study Results

No Results Posted as of May 30, 2012