Clinical trial NCT01876940: Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children
Official title: A Randomized Comparison of Free-handed Fiberoptic Intubation Compared With Fiberoptic Intubation Through an Air-QTM Intubating Laryngeal Airway in Children Less Than Two Years of Age: Does Operator Experience Affect Time to Successful Tracheal Intubation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fiberoptic Intubation in Children
Keywords: supraglottic airway
children
tracheal intubation
fiberoptic bronchoscopy
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?

Detailed description: The aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and peri-operative complications will also be assessed.

Eligibility criteria: Inclusion Criteria:

* Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries
* Age 1 month - 2 years
* Weight 1-20 Kg

Exclusion Criteria:

* Children with active respiratory infection
* Known history of difficult mask ventilation
* Diagnosis of a congenital syndrome associated with difficult airway management
* Airway abnormalities (e.g., laryngomalacia, subglottic stenosis).

Primary outcomes:
measure: Time for successful fiberoptic tracheal intubation
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes:
measure: Time to successful placement of the Air-Q
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 Air-Q
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Ease for placement of the air-Q
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: Peri-operative complications
timeFrame: Measured at 24 hours after device placement/study initiation
measure: Number of attempts for fiberoptic tracheal intubation
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Ease for fiberoptic tracheal intubation
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Lisa Sohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hodzovic I, Janakiraman C, Sudhir G, Goodwin N, Wilkes AR, Latto IP. Fibreoptic intubation through the laryngeal mask airway: effect of operator experience*. Anaesthesia. 2009 Oct;64(10):1066-71. doi: 10.1111/j.1365-2044.2009.06030.x.
citation: Hodzovic I, Petterson J, Wilkes AR, Latto IP. Fibreoptic intubation using three airway conduits in a manikin: the effect of operator experience. Anaesthesia. 2007 Jun;62(6):591-7. doi: 10.1111/j.1365-2044.2007.05054.x.
citation: Erb T, Marsch SC, Hampl KF, Frei FJ. Teaching the use of fiberoptic intubation for children older than two years of age. Anesth Analg. 1997 Nov;85(5):1037-41. doi: 10.1097/00000539-199711000-00013.
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.