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Nasotracheal Intubation Over a Bougie

NCT ID: NCT03003455

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nasotracheal Intubation Nasal Bleeding

Keywords

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Nasotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional Nasotracheal Intubation (CVT)

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

Group Type ACTIVE_COMPARATOR

Conventional Nasotracheal Intubation

Intervention Type 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

Nasotracheal Intubation Over a Bougie (NIB)

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

Group Type EXPERIMENTAL

Nasotracheal intubation over a bougie

Intervention Type PROCEDURE

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

Interventions

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Nasotracheal intubation over a bougie

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

Intervention Type PROCEDURE

Conventional Nasotracheal Intubation

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

Intervention Type PROCEDURE

Other Intervention Names

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Abrons technique for nasotracheal intubation Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet NIB CVT

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Abrons, Ron O

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Elwood T, Stillions DM, Woo DW, Bradford HM, Ramamoorthy C. Nasotracheal intubation: a randomized trial of two methods. Anesthesiology. 2002 Jan;96(1):51-3. doi: 10.1097/00000542-200201000-00014.

Reference Type BACKGROUND
PMID: 11753001 (View on PubMed)

O'Connell JE, Stevenson DS, Stokes MA. Pathological changes associated with short-term nasal intubation. Anaesthesia. 1996 Apr;51(4):347-50. doi: 10.1111/j.1365-2044.1996.tb07746.x.

Reference Type BACKGROUND
PMID: 8686823 (View on PubMed)

Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Can J Anaesth. 2006 Mar;53(3):295-8. doi: 10.1007/BF03022218.

Reference Type BACKGROUND
PMID: 16527796 (View on PubMed)

Abrons RO, Vansickle RA, Ouanes JP. Seldinger technique for nasal intubation: a case series. J Clin Anesth. 2016 Nov;34:609-11. doi: 10.1016/j.jclinane.2016.06.027. Epub 2016 Jul 19.

Reference Type BACKGROUND
PMID: 27687457 (View on PubMed)

Cossham PS. Nasotracheal tube placement over a bougie. Anaesthesia. 1997 Feb;52(2):184-5. No abstract available.

Reference Type BACKGROUND
PMID: 9059115 (View on PubMed)

Other Identifiers

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201112757

Identifier Type: -

Identifier Source: org_study_id