- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00885911
Evaluation of the Intubating Laryngeal Airway in Children
Evaluation of the Intubating Laryngeal Airway in Children - Phase 1
Study Overview
Status
Conditions
Detailed Description
Hypothesis: The Air-Q® intubating laryngeal airway (Air-Q® ILA) will: (1) perform satisfactorily as a primary airway; (2) perform comparably or better than the ProSeal™ LMA (PLMA); and (3) act as an excellent conduit for fibreoptic intubation.
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:
- To test the performance characteristics of the Air-Q® ILA as a primary airway in clinical pediatric anesthetic practice;
- To compare Air-Q® ILA performance to the current best option, the PLMA for sizes 1.0, 1.5, 2.0 and 2.5; To evaluate the performance characteristics of the Air-Q® ILA as a conduit for fibreoptic intubation
Methods:
Recruitment of subjects: With ethical and institutional review board approval, and with written parental informed consent, we will recruit children, ages 0-12 years, 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 1, the age/weight-appropriate Air-Q® ILA will be inserted in each child and assessed, using published, objective criteria. 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. In phase 3, the Air-Q® ILA will be inserted and, after ensuring adequate ventilation, a study investigator will undertake fibreoptic-guided endotracheal intubation through the Air-Q® ILA, after which the Air-Q® ILA will be removed. The performance characteristics of the Air-Q® ILA as a conduit for fibreoptic-guided endotracheal intubation will be evaluated.
Data analysis: Phase 1 will generate descriptive data on several validated performance characteristics. The primary outcome measure will be the oropharyngeal leak pressure (OLP) value. 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. In phase 3, the arterial oxygen saturation, heart rate, and rise in end-tidal CO2 will be reported as outcome variables, along with the time taken to complete the fibreoptic intubation. Descriptive data will be presented as mean ± SD, median (range), counts (percentages or proportions) as appropriate.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital Department of Anesthesia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ASA I-III
- Ideal body weight as determined from weight/height centile curves (> 3rd & < 97th centiles)
- Elective surgery
- Appropriate subject and procedure for airway management by LMA
Exclusion Criteria:
- ASA status IV-V
- Emergency surgery
- Abnormal or contraindicated cervical spine flexion/extension/rotation
Contraindication to LMA placement:
- Aspiration risk; gastro-oesophageal reflux disease
- Clinically significant pulmonary disease
- Coagulopathy
- Distorted airway anatomy judged likely to compromise LMA placement
- Allergy to any LMA components
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Extraglottic device
The laryngeal mask airway (LMA) used during pediatric anesthesia for routine and difficult airway management.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H08-01196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intubating Laryngeal Airway
-
University of British ColumbiaCompletedDevice - Intubating Laryngeal AirwayCanada
-
University of British ColumbiaCompleted
-
NHS TaysideTerminated
-
Konya Necmettin Erbakan ÜniversitesiRecruitingChildren | Airway Management | Laryngeal Mask AirwayTurkey
-
Asklepios Kliniken Hamburg GmbHUniversity of KielCompletedAirway Management | Laryngeal Mask Airway | Fibreoptic Intubation
-
Ajou University School of MedicineCompletedLaryngeal Mask AirwayKorea, Republic of
-
University of MalayaUnknownGeneral Anesthesia | Supraglottic Airway Device | Laryngeal Mask Airway
-
University of MalayaCompletedA Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kgLaryngeal Mask AirwayMalaysia
-
Yangzhou UniversityCompletedLaryngeal Mask Airway
-
Derince Training and Research HospitalCompletedLaryngeal Mask AirwayTurkey