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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320163
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):
Jin-Tae Kim, 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.

Condition or disease Intervention/treatment Phase
Endotracheal Intubation Device: i-gel airway (Intersurgical Ltd., Wokingham, England) Device: Laryngeal Mask Airway Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Intervention Details:
    Device: i-gel airway (Intersurgical Ltd., Wokingham, England)
    supra-glottic airway device
    Device: Laryngeal Mask Airway
    supra-glottic airway device

Primary Outcome Measures :
  1. airway leak pressure [ Time Frame: 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.

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Ages Eligible for Study:   1 Year to 9 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01320163

Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Jin-Tae Kim, assisstant professor, Seoul National University Hospital Identifier: NCT01320163     History of Changes
Other Study ID Numbers: H-1001-019-306
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012