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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01320163
First received: March 17, 2011
Last updated: May 26, 2012
Last verified: May 2012
  Purpose

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 Intervention
Endotracheal Intubation
Device: i-gel airway (Intersurgical Ltd., Wokingham, England)
Device: Laryngeal Mask Airway

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • airway leak pressure [ Time Frame: within 5 min of insertion of each device ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 108
Study Start Date: February 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: i-gel airway (Intersurgical Ltd., Wokingham, England)
    supra-glottic airway device
    Device: Laryngeal Mask Airway
    supra-glottic airway device
  Eligibility

Ages Eligible for Study:   1 Year to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320163

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

No publications provided

Responsible Party: Jin-Tae Kim, assisstant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01320163     History of Changes
Other Study ID Numbers: H-1001-019-306
Study First Received: March 17, 2011
Last Updated: May 26, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014