Evaluation of the Intubating Laryngeal Airway in Children

NCT01029431 | Completed Phase 3

• 1 other identifier: H08-02199
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically engineered for use both as a stand-alone 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. The objective of this study is to compare the Air-Q® ILA's performance to the current best option, the PLMA.

Conditions

Intubating Laryngeal Airway

Keywords

intubating laryngeal airway; pediatric

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure is the most commonly reported primary outcome measure of LMA performance. If fresh gas destined for the lung alveoli leaks around the LMA, inadequate ventilation may result, leading to respiratory acidosis.

  10 minutes

Study Arms (1)

1

EXPERIMENTAL

All subjects will have both Air-Q ILA \& PLMA

Device: AirQ Intubating Laryngeal Airway

Interventions

AirQ Intubating Laryngeal Airway DEVICE

After induction of anaesthesia in each child, either a PLMA or an Air-Q® ILA of the weight-appropriate size will be inserted \& the evaluation described below will be conducted. The first LMA will then be removed \& the other device inserted \& assessed. The order in which the LMA devices are inserted will be determined using block randomisation, with random block sizes, after recruitment \& before induction of anesthesia. The anesthesiologist will insert the LMAs using the manufacturer's recommended technique, \& inflate the cuff to the manufacturer's recommended intracuff pressure of 60 cm H2O. Intracuff pressure will be measured with a digital pressure cuff monitor.

1

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• ASA I-III
• Ideal body weight as determined from weight/height centile curves (\>3rd \& \<97th centiles).
• Elective surgery
• Appropriate subject and procedure for airway management by LMA sizes 1, 1.5, 2 or 2.5 (Weight 0-50 kg).
• ASA status IV-V
• Emergency surgery
• Abnormal or contraindicated cervical spine flexion/extension/rotation
• Contraindication to LMA placement
• Aspiration risk; gastro-oesophageal reflux disease
• Clinically significant pulmonary disease
• Coagulopathy
• Distorted airway anatomy judged likely to compromise LMA placement
• Allergy to any LMA components.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital, Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Study Officials

• Simon Whyte, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Stephan Malherbe, MD

  University of British Columbia

  STUDY DIRECTOR

• Andrew Morrison, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

CA (1)