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

Not Applicable

Completed

• Conditions: Fiberoptic Intubation in Children
• Interventions: Device: air-Q, followed by fiberoptic intubation; Device: Free-hand Fiberoptic Intubation

• Registration Number: NCT01876940
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-13
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiberoptic Intubation performed by an expert	air-Q, followed by fiberoptic intubation	Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q
Fiberoptic Intubation performed by an expert	Free-hand Fiberoptic Intubation	Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q
Fiberoptic Intubation performed by a novice	air-Q, followed by fiberoptic intubation	Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q
Fiberoptic Intubation performed by a novice	Free-hand Fiberoptic Intubation	Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q

Primary Outcome Measures

Name	Time	Method
Time for successful fiberoptic tracheal intubation	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	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.

Secondary Outcome Measures

Name	Time	Method
Time to successful placement of the Air-Q	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	Successful placement of the air-Q will start with the removal of the facemask until presence of end-tidal CO2 is confirmed.
Number of attempts to place the Air-Q	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)
Ease for placement of the air-Q	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	The ease for Air-Q placement will be assessed using a subjective scale
Fiberoptic grade of laryngeal view	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	The laryngeal alignment through the devices will be graded using an established scoring system
Peri-operative complications	Measured at 24 hours after device placement/study initiation	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.
Number of attempts for fiberoptic tracheal intubation	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	Number of attempts needed for successful fiberoptic tracheal intubation will be recorded (maximum of 3 attempts will be considered as a failure)
Ease for fiberoptic tracheal intubation	Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	The ease for fiberoptic tracheal intubation will be assessed using a subjective scale

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States