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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014