Completed

NCT Number: NCT01876940

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

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?

Completed

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Key information

Conditions

Fiberoptic Intubation in Children

Age range

1 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

air-Q, followed by fiberoptic intubation

Device

Other names: Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Free-hand Fiberoptic Intubation

Device

Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed

Primary outcomes

Time for successful fiberoptic tracheal intubation

Time frame: 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 outcomes

Time to successful placement of the Air-Q

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study 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?

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jun 13, 2013
Registry last updated: Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.