Evaluation of the Intubating Laryngeal Airway in Children
1 other identifier
observational
110
1 country
1
Brief Summary
The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically engineered for use both as a stand-alone laryngeal mask airway (LMA) and as a rescue device or "Plan B" device in the event of a difficult airway. As with some other types of LMA, it is then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. This will be a prospective observational study of the Air-Q® ILA's performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 20, 2009
CompletedFirst Posted
Study publicly available on registry
April 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJune 26, 2017
June 1, 2017
3.5 years
April 20, 2009
June 22, 2017
Conditions
Keywords
Study Arms (1)
Extraglottic device
The laryngeal mask airway (LMA) used during pediatric anesthesia for routine and difficult airway management.
Eligibility Criteria
Perioperative safety for children. A device that would be an invaluable addition to difficult pediatric airway management plans, increasing the likelihood of quickly and effectively securing the difficult airway, and decreasing the risk of catastrophic hypoxemia.
You may qualify if:
- ASA I-III
- Ideal body weight as determined from weight/height centile curves (\> 3rd \& \< 97th centiles)
- Elective surgery
- Appropriate subject and procedure for airway management by LMA
You may not qualify if:
- ASA status IV-V
- Emergency surgery
- Abnormal or contraindicated cervical spine flexion/extension/rotation
- Contraindication to LMA placement:
- Aspiration risk; gastro-oesophageal reflux disease
- Clinically significant pulmonary disease
- Coagulopathy
- Distorted airway anatomy judged likely to compromise LMA placement
- Allergy to any LMA components
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
British Columbia Children's Hospital Department of Anesthesia
Vancouver, British Columbia, V6H 3V4, Canada
Related Publications (1)
Whyte SD, Cooke E, Malherbe S. Usability and performance characteristics of the pediatric air-Q(R) intubating laryngeal airway. Can J Anaesth. 2013 Jun;60(6):557-63. doi: 10.1007/s12630-013-9918-6. Epub 2013 Mar 22.
PMID: 23519724DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Whyte, MD
University of British Columbia
- STUDY DIRECTOR
Stephan Malherbe, MD
University of British Columbia
- STUDY DIRECTOR
Andrew Morrison, MD
University of British Columbia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 20, 2009
First Posted
April 22, 2009
Study Start
March 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
June 26, 2017
Record last verified: 2017-06