A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

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.

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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.

Conditions

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Tracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal Route

The nasal route will be when the airway is acquired and secured with a fiberoptic bronchoscope through one of the nares.

Group Type OTHER

Fiberoptic Intubation through the nasal route

Intervention Type OTHER

Oral Route

The oral route will be when the airway is acquired and secured with a fiberoptic bronchoscope through the patient's mouth.

Group Type OTHER

Fiberoptic intubation through the oral route

Intervention Type OTHER

Interventions

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Fiberoptic Intubation through the nasal route

Intervention Type OTHER

Fiberoptic intubation through the oral route

Intervention Type OTHER

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes