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Evaluation of the Intubating Laryngeal Airway in Children

NCT01029431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-06-26

No results posted yet for this study

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

Interventions

DEVICE

AirQ Intubating Laryngeal Airway

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Simon Whyte, MD · University of British Columbia

  • Stephan Malherbe, MD · University of British Columbia

  • Andrew Morrison, MD · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01029431 on ClinicalTrials.gov