NCT01029431|CompletedPhase 3
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Sponsor study identifier
interventional
90
1 country
1
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 7, 2009
Actual (reported)December 10, 2009
Actual (reported)August 2013
Actual (reported)August 2013
Actual (reported)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
All subjects will have both Air-Q ILA \& PLMA
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
British Columbia Children's Hospital, Department of Anesthesia
Vancouver, British Columbia, V6H 3V4, Canada
Simon Whyte, MD
University of British Columbia
Stephan Malherbe, MD
University of British Columbia
Andrew Morrison, MD
University of British Columbia
90 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2009
First Posted
December 10, 2009
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
June 26, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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