Evaluation of the Intubating Laryngeal Airway in Children
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.
Device - Intubating Laryngeal Airway
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation of the Intubating Laryngeal Airway in Children - Phase 3|
- Time of intubation [ Time Frame: from start of fibreoptic intubation to end ] [ Designated as safety issue: No ]
- arterial oxygen saturation [ Time Frame: during intubation ] [ Designated as safety issue: No ]
- heart rate [ Time Frame: during intubation ] [ Designated as safety issue: No ]
- rise in end-tidal CO2 [ Time Frame: during intubation ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
|Study Start Date:||December 2010|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233011
|Canada, British Columbia|
|British Columbia Children's Hospital, Department of Anesthesia|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Simon White, Dr.||University of British Columbia|