A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children

Tracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029300
• Other study ID #: 2014-15520
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: May 24, 2014
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Other:
• Fiberoptic Intubation through the nasal route

• Fiberoptic intubation through the oral route

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wheeler M, Roth AG, Dsida RM, Rae B, Seshadri R, Sullivan CL, Heffner CL, Coté 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to first glottic view	This will be measuring the time it takes the anesthesiologist to have the first glottic view.	during tracheal intubation	No
Other	Time to carinal view	This is the time it will take the anesthesiologist to the first carinal view.	during tracheal intubation	No
Other	Time to successful intubation	This will measure the entire time period it takes for the ansthesiologist to intubate the patient.	during tracheal intubation	No
Other	Complications	Complications 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	From the beginning to the end of intubation, and after the surgery up to 24 hours post-op	Yes
Primary	Time to fiberoptic intubation		From disconnection of oxygen to reconnection of oxygen during tracheal intubation	No