Evaluation of the Intubating Laryngeal Airway in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01233011
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):
Simon Whyte, University of British Columbia

Brief Summary:
The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically engineered for use both as a standalone 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.

Condition or disease
Device - Intubating Laryngeal Airway

Detailed Description:

Hypothesis: The Air-Q® intubating laryngeal airway (Air-Q® ILA) will act as an excellent conduit for fibreoptic intubation.

Background: The laryngeal mask airway (LMA) is used during pediatric anesthesia for routine and difficult airway management. The ideal pediatric LMA device would provide excellent sealing at low pressure; facilitate easy endotracheal intubation; and be available in pediatric sizes. Such a device would be an invaluable addition to difficult pediatric airway management plans and, by increasing the likelihood of quickly and effectively securing the difficult airway, and decreasing the risk of catastrophic hypoxemia, would increase perioperative safety for children. The Air-Q® ILA is a modified LMA device whose features encompass the characteristics of the ideal LMA. Our objective is to determine whether or not this new airway device is an improvement over the current standard of care.

Specific Objectives:

To evaluate the performance characteristics of the Air-Q® ILA as a conduit for fibreoptic intubation


Recruitment of subjects: With ethical and institutional review board approval, and with written parental informed consent, we will recruit children undergoing elective surgery. Children with ASA status IV-V, abnormal or contraindicated cervical spine flexion/extension/rotation, contraindication to LMA placement, or requiring emergency surgery will be excluded. All children will undergo intravenous induction of anesthesia, as per our routine institutional practice.

Administration of Air-Q® ILA: The Air-Q® ILA will be inserted and, after ensuring adequate ventilation, a study investigator will undertake fibreoptic-guided endotracheal intubation through the Air-Q® ILA, after which the Air-Q® ILA will be removed. The performance characteristics of the Air-Q® ILA as a conduit for fibreoptic-guided endotracheal intubation will be evaluated.

Data analysis: The arterial oxygen saturation, heart rate, and rise in end-tidal CO2 will be reported as outcome variables, along with the time taken to complete the fibreoptic intubation. Descriptive data will be presented as mean ± SD, median (range), counts (percentages or proportions) as appropriate.

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Intubating Laryngeal Airway in Children - Phase 3
Study Start Date : December 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Primary Outcome Measures :
  1. Time of intubation [ Time Frame: from start of fibreoptic intubation to end ]

Secondary Outcome Measures :
  1. arterial oxygen saturation [ Time Frame: during intubation ]
  2. heart rate [ Time Frame: during intubation ]
  3. rise in end-tidal CO2 [ Time Frame: during intubation ]

Biospecimen Retention:   None Retained
No biospecimens.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy male and female pediatric subjects presenting for surgery through Surgical Day Care Unit.

Inclusion Criteria:

  • Ideal body weight as determined from weight/height centile curves (>3rd & <97th centiles). Wei
  • Elective surgery
  • Appropriate subject and procedure for airway management by endotracheal intubation.

Exclusion Criteria:

  • ASA status IV-V
  • Emergency surgery
  • Anticipated difficult intubation
  • Contraindication to LMA placement
  • Aspiration risk; gastro-esophageal reflux disease
  • Clinically significant pulmonary disease
  • Coagulopathy
  • Distorted airway anatomy judged likely to compromise LMA placement
  • Allergy to any LMA components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01233011

Canada, British Columbia
British Columbia Children's Hospital, Department of Anesthesia
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Simon White, Dr. University of British Columbia

Additional Information:
Responsible Party: Simon Whyte, Principle Investigator, University of British Columbia Identifier: NCT01233011     History of Changes
Other Study ID Numbers: H09-01389
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by Simon Whyte, University of British Columbia:
Intubating laryngeal airway
Observational study