Evaluation of the Intubating Laryngeal Airway in Children

This study is currently recruiting participants.
Verified September 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01029431
First received: December 7, 2009
Last updated: September 25, 2012
Last verified: September 2012

December 7, 2009
September 25, 2012
December 2009
October 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029431 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Intubating Laryngeal Airway in Children
Evaluation of the Intubating Laryngeal Airway in Children - Phase 2

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.

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.

Specific Objectives:

The objective of this study is to compare the Air-Q® ILA's performance to the current best option, the PLMA.

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: 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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Intubating Laryngeal Airway
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.
Experimental: 1
All subjects will have both Air-Q ILA & PLMA
Intervention: Device: AirQ Intubating Laryngeal Airway
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Eligibility Key inclusion and exclusion criteria Inclusion:

  1. ASA I-III
  2. Ideal body weight as determined from weight/height centile curves (>3rd & <97th centiles).
  3. Elective surgery
  4. Appropriate subject and procedure for airway management by LMA sizes 1, 1.5, 2 or 2.5 (Weight 0-50 kg).

Exclusion Criteria:

  1. ASA status IV-V
  2. Emergency surgery
  3. Abnormal or contraindicated cervical spine flexion/extension/rotation
  4. Contraindication to LMA placement
  5. Aspiration risk; gastro-oesophageal reflux disease
  6. Clinically significant pulmonary disease
  7. Coagulopathy
  8. Distorted airway anatomy judged likely to compromise LMA placement
  9. Allergy to any LMA components.
Both
up to 16 Years
Yes
Contact: Joanne Lim jlim2@cw.bc.ca
Canada
 
NCT01029431
H08-02199
No
University of British Columbia
University of British Columbia
Not Provided
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
University of British Columbia
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP