Evaluation of the Intubating Laryngeal Airway in Children

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Intubating Laryngeal Airway
Device: AirQ Intubating Laryngeal Airway
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Intubating Laryngeal Airway in Children - Phase 2

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: December 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029431

Contacts
Contact: Joanne Lim jlim2@cw.bc.ca

Locations
Canada, British Columbia
British Columbia Children's Hospital, Department of Anesthesia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Joanne Lim       jlim2@cw.bc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01029431     History of Changes
Other Study ID Numbers: H08-02199
Study First Received: December 7, 2009
Last Updated: September 25, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
intubating laryngeal airway
pediatric

ClinicalTrials.gov processed this record on August 21, 2014