Evaluation of the Intubating Laryngeal Airway in Children
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|ClinicalTrials.gov Identifier: NCT01029431|
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : June 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intubating Laryngeal Airway||Device: AirQ Intubating Laryngeal Airway||Phase 3|
Hypothesis: The hypothesis is that, for each of the four ILA size categories, 1.0, 1.5, 2.0 & 2.5:
H0: Mean oropharyngeal leak pressure with Air-Q® ILA= mean oropharyngeal leak pressure with PLMA.
H1: Mean oropharyngeal leak pressure with Air-Q® ILA≠ mean oropharyngeal leak pressure with PLMA.
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.
The objective of this study is to compare the Air-Q® ILA's performance to the current best option, the PLMA.
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: In phase 2, either a PLMA or an Air-Q® ILA will be inserted and assessed. The first LMA will then be removed and the other device inserted and assessed. The order of insertion will be determined by block randomization.
Data analysis: In phase 2, we will compare OLP values using paired t- tests. We will conduct appropriate statistical analysis of the data on the other assessment variables, which are all secondary outcome measures. Descriptive data will be presented as mean ± SD, median (range), counts (percentages or proportions) as appropriate.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Intubating Laryngeal Airway in Children - Phase 2|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
All subjects will have both Air-Q ILA & PLMA
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.
- 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. [ Time Frame: 10 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029431
|Canada, British Columbia|
|British Columbia Children's Hospital, Department of Anesthesia|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Simon Whyte, MD||University of British Columbia|
|Study Director:||Stephan Malherbe, MD||University of British Columbia|
|Study Director:||Andrew Morrison, MD||University of British Columbia|