Evaluation of the Intubating Laryngeal Airway in Children

Evaluation of the Intubating Laryngeal Airway in Children - Phase 3

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.

Study Overview

• Status: Completed
• Conditions: 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

Methods:

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
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital, Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female pediatric subjects presenting for surgery through Surgical Day Care Unit.

Description

Inclusion Criteria:

• ASA I-III
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of intubation	from start of fibreoptic intubation to end

Secondary Outcome Measures

Outcome Measure	Time Frame
arterial oxygen saturation	during intubation
heart rate	during intubation
rise in end-tidal CO2	during intubation

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Simon White, Dr., University of British Columbia

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (ESTIMATE): November 2, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Pediatric; Observational study; Intubating laryngeal airway
• Other Study ID Numbers: H09-01389