A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children

Study Overview
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Brief Summary
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There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In general, nasal intubation by any conventional method may be the preferred choice for certain procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth opening. If nasal intubation is not indicated or preferred, then oral intubation is usually performed. This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. This study will also examine if operator experience influence time to tracheal intubation with either route? The investigators hypothesize that the nasal route of fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.

Detailed Description
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The goal of this prospective randomized study is to compare the effect of nasal fiberoptic intubation versus oral fiberoptic intubation in children less than 2 years of age. Other factors that will be assesed include operator experience, the ease and time for fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and complications. This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. While also asking, will operator experience influence time to tracheal intubation with either route? The investigators hypothesize that the nasal route fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.

Official Title
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A Randomized Comparison of Nasal Versus Oral Fiberoptic Intubation in Children Less Than Two Years of Age

Conditions
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Tracheal Intubation

Intervention / Treatment
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* Other: Fiberoptic Intubation through the nasal route
* Other: Fiberoptic intubation through the oral route


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children ASA I to III Patients less than or equal to 2 years of age Patients with scheduled surgeries in which endotracheal intubation is part of their general anesthetic plan Exclusion Criteria: Children with ASA IV or V Children with active respiratory infection, pulmonary disease, a known history of difficult mask ventilation, high suspicion of difficult airway (secondary to congenital syndromes for example), and significant airway abnormalities

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nasal Route<br>The nasal route will be when the airway is acquired and secured with a fiberoptic bronchoscope through one of the nares. | Other: Fiberoptic Intubation through the nasal route<br> <br> |
| Other: Oral Route<br>The oral route will be when the airway is acquired and secured with a fiberoptic bronchoscope through the patient's mouth. | Other: Fiberoptic intubation through the oral route<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fiberoptic intubation |  | From disconnection of oxygen to reconnection of oxygen during tracheal intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, fiberoptic intubation, oral intubation, nasal intubation, children under the age of 2