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

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation
• Intervention / Treatment: Other: Fiberoptic Intubation through the nasal route; Other: Fiberoptic intubation through the oral route

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Nasal Route; The nasal route will be when the airway is acquired and secured with a fiberoptic bronchoscope through one of the nares.	Other: Fiberoptic Intubation through the nasal route
OTHER: Oral Route; The oral route will be when the airway is acquired and secured with a fiberoptic bronchoscope through the patient's mouth.	Other: Fiberoptic intubation through the oral route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to fiberoptic intubation	From disconnection of oxygen to reconnection of oxygen during tracheal intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first glottic view	This will be measuring the time it takes the anesthesiologist to have the first glottic view.	during tracheal intubation
Time to carinal view	This is the time it will take the anesthesiologist to the first carinal view.	during tracheal intubation
Time to successful intubation	This will measure the entire time period it takes for the ansthesiologist to intubate the patient.	during tracheal intubation
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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Narasimhan Jagannathan, MD, Lurie Childrens Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (ESTIMATE): January 7, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2014
• Last Update Submitted That Met QC Criteria: May 24, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: pediatrics; nasal intubation; fiberoptic intubation; oral intubation; children under the age of 2
• Other Study ID Numbers: 2014-15520