Device - Intubating Laryngeal Airway
Conditions
Keywords
Intubating laryngeal airway, Pediatric, Observational study
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.
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.
Interventions
None listed
Sponsors
University of British Columbia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of intubation | from start of fibreoptic intubation to end |
Secondary
| Measure | Time frame |
|---|---|
| arterial oxygen saturation | during intubation |
| heart rate | during intubation |
| rise in end-tidal CO2 | during intubation |
Countries
Canada
Outcome results
None listed