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Completed

NCT Number: NCT03003455

Nasotracheal Intubation Over a Bougie

The purpose of this study is to determine whether nasal intubation over a bougie placed via a nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind nasal endotracheal tube passage.

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Key information

Age range

8 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

Conventional nasotracheal intubation techniques (or "Conventional Videolaryngoscopic Techniques," CVT) are known to be associated with significant trauma to the patient's nares and the endotracheal tube itself. The investigators propose an alternative technique (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which promises to not only be less traumatic to the patient and the endotracheal tube, but also to take less time to perform and have a higher first-attempt success rate than conventional methods. The investigators propose a randomized prospective interventional study comparing this new technique with conventional technique to see if a significant difference exists.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients scheduled for elective surgery with an anesthetic plan including asleep nasotracheal intubation

Exclusion criteria

  • Patients needing emergent airway protection
  • Patients undergoing emergency surgery
  • Patients whom are known to be pregnant
  • Patients whom are currently anticoagulated (including daily aspirin use)
  • Patients whose anesthetic includes the use of nitrous oxide
  • Patients whom are currently incarcerated
  • Patients 7 years of age or younger
  • Mentally incompetent adults
  • Patients whom refuse involvement in the study

Treatment and study plan

Nasotracheal intubation over a bougie

Procedure

Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps

Other names: Abrons technique for nasotracheal intubation, Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, NIB

Conventional Nasotracheal Intubation

Procedure

Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps

Other names: CVT

Primary outcomes

  1. Nasal trauma

    Time frame: 60-90 seconds post-intubation

    Bleeding noted on nasopharyngeal exam by surgical resident

Secondary outcomes

  1. Nasal trauma

    Time frame: 5 minutes post-intubation

    Bleeding noted on nasopharyngeal exam by surgical resident

  2. Time to intubation

    Time frame: Measured immediately post-intubation

    Time from first entrance of ETT or bougie into the nare to the presence of end-tidal CO2 via nasotracheal ETT

  3. First attempt success rate

    Time frame: Measured immediately post-intubation

    Whether or not there was successful nasotracheal intubation on the first attempt

  4. Need for Magill forceps

    Time frame: Measured Immediately post-intubation

    Whether or not Magill forceps were used during airway management

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 28, 2016
Registry last updated
Dec 28, 2016

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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