Evaluation of the Intubating Laryngeal Airway in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Intubating Laryngeal Airway in Children - Phase 3

Conditions
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Device - Intubating Laryngeal Airway

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of intubation |  | from start of fibreoptic intubation to end | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubating laryngeal airway, Pediatric, Observational study