Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children

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?

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?

Study Overview

• Status: Completed
• Conditions: Fiberoptic Intubation in Children
• Intervention / Treatment: Device: air-Q, followed by fiberoptic intubation; Device: Free-hand Fiberoptic Intubation

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fiberoptic Intubation performed by an expert; Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q	Device: air-Q, followed by fiberoptic intubation; Other Names: Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed; Device: Free-hand Fiberoptic Intubation; Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed
Experimental: Fiberoptic Intubation performed by a novice; Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q	Device: air-Q, followed by fiberoptic intubation; Other Names: Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed; Device: Free-hand Fiberoptic Intubation; Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for successful fiberoptic tracheal intubation	The time for successful intubation will be from removal of the face mask or disconnection of the circuit from the air-Q until evidence of end-tidal CO2 is confirmed.	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fiberoptic grade of laryngeal view	The laryngeal alignment through the devices will be graded using an established scoring system	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Time to successful placement of the Air-Q	Successful placement of the air-Q will start with the removal of the facemask until presence of end-tidal CO2 is confirmed.	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Number of attempts to place the Air-Q	Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease for placement of the air-Q	The ease for Air-Q placement will be assessed using a subjective scale	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Peri-operative complications	Includes: Complications during the placement of the Air-Q (Laryngospasm, Bronchospasm, Desaturation, etc. Oropharyngolaryngeal morbidity at discharge, participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours. Oropharyngolaryngeal morbidity at 24 hours post-operatively, measured at 24 hours after device placement/study initiation. These will be assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.	Measured at 24 hours after device placement/study initiation
Number of attempts for fiberoptic tracheal intubation	Number of attempts needed for successful fiberoptic tracheal intubation will be recorded (maximum of 3 attempts will be considered as a failure)	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease for fiberoptic tracheal intubation	The ease for fiberoptic tracheal intubation will be assessed using a subjective scale	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Narasimhan Jagannathan, MD, Ann & Robert H Lurie Children's Hospital of Chicago; Principal Investigator: Lisa Sohn, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 13, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: children; tracheal intubation; fiberoptic bronchoscopy; supraglottic airway
• Other Study ID Numbers: IRB#2013-15391