Clinical trial NCT01535742: Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children
Official title: Prospective Randomized Comparison of the Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation in Children
Keywords: laryngeal mask airway
children
tracheal intubation
fiberoptic bronchoscopy
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.

Detailed description: The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.

Eligibility criteria: Inclusion Criteria:

* Children undergoing general anesthesia requiring tracheal intubation
* Weight 5-20 kg
* Age one month-six years

Exclusion Criteria:

* ASA class IV, V Emergency procedures
* History of a difficult airway
* Active upper respiratory tract infection
* Children receiving emergent surgery

Primary outcomes:
measure: Ease and time to successful tracheal intubation
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes:
measure: Ease and time to place airway
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Number of attempts to place the supraglottic device and tracheal tube
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Airway Leak Pressure
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Fiberoptic grade of laryngeal view
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Time to remove device
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Airway maneuvers
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Adverse effects
timeFrame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jagannathan N, Sohn LE, Mankoo R, Langen KE, Mandler T. A randomized crossover comparison between the Laryngeal Mask Airway-Unique and the air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2012 Feb;22(2):161-7. doi: 10.1111/j.1460-9592.2011.03703.x. Epub 2011 Sep 15.
citation: Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.
citation: Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x.
citation: Baker PA, Brunette KE, Byrnes CA, Thompson JM. A prospective randomized trial comparing supraglottic airways for flexible bronchoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):831-8. doi: 10.1111/j.1460-9592.2010.03362.x.