A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children

Not Applicable

Completed

• Conditions: Tracheal Intubation
• Interventions: Other: Fiberoptic Intubation through the nasal route; Other: Fiberoptic intubation through the oral route

• Registration Number: NCT02029300
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-24
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal Route	Fiberoptic Intubation through the nasal route	The nasal route will be when the airway is acquired and secured with a fiberoptic bronchoscope through one of the nares.
Oral Route	Fiberoptic intubation through the oral route	The oral route will be when the airway is acquired and secured with a fiberoptic bronchoscope through the patient's mouth.

Primary Outcome Measures

Name	Time	Method
Time to fiberoptic intubation	From disconnection of oxygen to reconnection of oxygen during tracheal intubation

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States