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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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01876940
Enrollment
80
Registered
2013-06-13
Start date
2013-06-30
Completion date
2013-07-31
Last updated
2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fiberoptic Intubation in Children

Keywords

supraglottic airway, children, tracheal intubation, fiberoptic bronchoscopy

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.

Interventions

DEVICEair-Q, followed by fiberoptic intubation
DEVICEFree-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

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 2 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Time for successful fiberoptic tracheal intubationParticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursThe 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

MeasureTime frameDescription
Number of attempts to place the Air-QParticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursNumber 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-QParticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursThe ease for Air-Q placement will be assessed using a subjective scale
Fiberoptic grade of laryngeal viewParticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursThe laryngeal alignment through the devices will be graded using an established scoring system
Time to successful placement of the Air-QParticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursSuccessful placement of the air-Q will start with the removal of the facemask until presence of end-tidal CO2 is confirmed.
Number of attempts for fiberoptic tracheal intubationParticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursNumber 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 intubationParticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursThe ease for fiberoptic tracheal intubation will be assessed using a subjective scale
Peri-operative complicationsMeasured at 24 hours after device placement/study initiationIncludes: 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026