Clinical trial NCT02029300: A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children
Official title: A Randomized Comparison of Nasal Versus Oral Fiberoptic Intubation in Children Less Than Two Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Keywords: pediatrics
fiberoptic intubation
oral intubation
nasal intubation
children under the age of 2
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to fiberoptic intubation
timeFrame: From disconnection of oxygen to reconnection of oxygen during tracheal intubation
Secondary outcomes:
Other outcomes:
measure: Time to first glottic view
timeFrame: during tracheal intubation
measure: Time to carinal view
timeFrame: during tracheal intubation
measure: Time to successful intubation
timeFrame: during tracheal intubation
measure: Complications
timeFrame: From the beginning to the end of intubation, and after the surgery up to 24 hours post-op
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Lurie Childrens Hospital
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wheeler M, Roth AG, Dsida RM, Rae B, Seshadri R, Sullivan CL, Heffner CL, Cote CJ. Teaching residents pediatric fiberoptic intubation of the trachea: traditional fiberscope with an eyepiece versus a video-assisted technique using a fiberscope with an integrated camera. Anesthesiology. 2004 Oct;101(4):842-6. doi: 10.1097/00000542-200410000-00007.
citation: Jagannathan N, Sequera-Ramos L, Sohn L, Huang A, Sawardekar A, Wasson N, Miriyala A, De Oliveira GS. Randomized comparison of experts and trainees with nasal and oral fibreoptic intubation in children less than 2 yr of age. Br J Anaesth. 2015 Feb;114(2):290-6. doi: 10.1093/bja/aeu370. Epub 2014 Nov 5.