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A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02029300
Enrollment
100
Registered
2014-01-07
Start date
2013-11-30
Completion date
2014-03-31
Last updated
2014-05-28

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

Conditions

Tracheal Intubation

Keywords

pediatrics, fiberoptic intubation, oral intubation, nasal intubation, children under the age of 2

Brief summary

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

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.

Interventions

OTHERFiberoptic Intubation through the nasal route
OTHERFiberoptic intubation through the oral route

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frame
Time to fiberoptic intubationFrom disconnection of oxygen to reconnection of oxygen during tracheal intubation

Other

MeasureTime frameDescription
Time to first glottic viewduring tracheal intubationThis will be measuring the time it takes the anesthesiologist to have the first glottic view.
Time to carinal viewduring tracheal intubationThis is the time it will take the anesthesiologist to the first carinal view.
Time to successful intubationduring tracheal intubationThis will measure the entire time period it takes for the ansthesiologist to intubate the patient.
ComplicationsFrom the beginning to the end of intubation, and after the surgery up to 24 hours post-opComplications will be recorded and defined as follows: * laryngospasm: clinical evidence of inability to ventilate * bronchospasm: bilaterally inspiratory and expiratory wheezing along with potential desaturations and changes in capnogram morphology * desaturation: SpO2 (blood oxygen saturation) below 90% at any time during the case

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026