NCT01314248

Brief Summary

The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. The investigators goal for this study is to compare the performance of the ILA with the current standard of care the standard LMA during routine anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

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

December 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

March 10, 2011

Last Update Submit

July 29, 2013

Conditions

Children

Keywords

airway sealing pressurefiberoptic assessmentease and time for successful insertionincidence of gastric insufflationcomplications were also evaluated

Study Arms (1)

children weighing 10 to 15 kg

Device: each child will receive both the LMA and ILA

Interventions

each child will receive both the LMA and ILADEVICE

each child will receive both the size 2 LMA and size 1.5 ILA

children weighing 10 to 15 kg

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy children undergoing general anesthesia for their scheduled elective outpatient surgeries using a supraglottic airway device for airway maintenance.

You may qualify if:

  • Healthy children undergoing general anesthesia using a supraglottic airway device
  • months to 36 months of age
  • to 15 kilograms in weight

You may not qualify if:

  • Active respiratory infection
  • History of difficult mask ventilation
  • Features or history of a difficult airway
  • Gastrointestinal reflux disease
  • Clinically significant pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Jagannathan N, Sohn LE, Mankoo R, Langen KE, Mandler T. A randomized crossover comparison between the Laryngeal Mask Airway-Unique and the air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2012 Feb;22(2):161-7. doi: 10.1111/j.1460-9592.2011.03703.x. Epub 2011 Sep 15.

    PMID: 21917058DERIVED

Study Officials

  • Narasimhan Jagannathan, MD

    Childrens Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 14, 2011

Study Start

December 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

US(1)