Evaluation of the Intubating Laryngeal Airway in Children

This study is currently recruiting participants.
Verified January 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01233011
First received: November 1, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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
Device - Intubating Laryngeal Airway

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Intubating Laryngeal Airway in Children - Phase 3

Further study details as provided by University of British Columbia:

Biospecimen Retention:   None Retained

No biospecimens.


Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233011

Contacts
Contact: Simon Whyte, Dr 604 875-2711 swhyte@cw.bc.ca
Contact: Joanne Lim jlim2@cw.bc.ca

Locations
Canada, British Columbia
British Columbia Children's Hospital, Department of Anesthesia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Joanne Lim         
Contact: Simon Whyte, Dr.    604-875-2711    swhyte@cw.bc.ca   
Principal Investigator: Simon Whyte, Dr.         
Sub-Investigator: Joanne Lim         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Simon White, Dr. University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01233011     History of Changes
Other Study ID Numbers: H09-01389
Study First Received: November 1, 2010
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Intubating laryngeal airway
Pediatric
Observational study

ClinicalTrials.gov processed this record on April 21, 2014