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Completed

NCT Number: NCT02029300

A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children

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.

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Key information

Conditions

Tracheal Intubation

Age range

1 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiberoptic Intubation through the nasal route

Other

Fiberoptic intubation through the oral route

Other

Primary outcomes

  1. Time to fiberoptic intubation

    Time frame: From disconnection of oxygen to reconnection of oxygen during tracheal intubation

Other outcomes

  1. Time to first glottic view

    Time frame: during tracheal intubation

    This will be measuring the time it takes the anesthesiologist to have the first glottic view.

  2. Time to carinal view

    Time frame: during tracheal intubation

    This is the time it will take the anesthesiologist to the first carinal view.

  3. Time to successful intubation

    Time frame: during tracheal intubation

    This will measure the entire time period it takes for the ansthesiologist to intubate the patient.

  4. Complications

    Time frame: From the beginning to the end of intubation, and after the surgery up to 24 hours post-op

    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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2014
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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