NCT01320163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

March 17, 2011

Last Update Submit

May 26, 2012

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

i-gel airway (Intersurgical Ltd., Wokingham, England)DEVICE

supra-glottic airway device

Laryngeal Mask AirwayDEVICE

supra-glottic airway device

Eligibility Criteria

Age1 Year - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary

You may not qualify if:

  • Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status
  • upper airway abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 22, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

KR(1)