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NCT01320163 Clinical Trial

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

Endotracheal Intubation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01320163
Other study ID # H-1001-019-306
Secondary ID
Status Completed
Phase N/A
First received March 17, 2011
Last updated May 26, 2012
Start date February 2011
Est. completion date July 2011

Study information
Verified date May 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 9 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul national university hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary airway leak pressure 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. within 5 min of insertion of each device Yes
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