NCT03003455

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

3.9 years

First QC Date

December 19, 2016

Last Update Submit

December 21, 2016

Conditions

Nasotracheal IntubationNasal Bleeding

Keywords

Nasotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Nasal trauma

    Bleeding noted on nasopharyngeal exam by surgical resident

    60-90 seconds post-intubation

Secondary Outcomes (4)

  • Nasal trauma

    5 minutes post-intubation

  • Time to intubation

    Measured immediately post-intubation

  • First attempt success rate

    Measured immediately post-intubation

  • Need for Magill forceps

    Measured Immediately post-intubation

Study Arms (2)

Conventional Nasotracheal Intubation (CVT)

ACTIVE COMPARATOR

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

Procedure: Conventional Nasotracheal Intubation

Nasotracheal Intubation Over a Bougie (NIB)

EXPERIMENTAL

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

Procedure: Nasotracheal intubation over a bougie

Interventions

Nasotracheal intubation over a bougiePROCEDURE

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

Also known as: Abrons technique for nasotracheal intubation, Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, NIB
Nasotracheal Intubation Over a Bougie (NIB)
Conventional Nasotracheal IntubationPROCEDURE

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

Also known as: CVT
Conventional Nasotracheal Intubation (CVT)

Eligibility Criteria

Age8 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

  • 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.

    PMID: 11753001BACKGROUND

  • 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.

    PMID: 8686823BACKGROUND

  • 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.

    PMID: 16527796BACKGROUND

  • 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.

    PMID: 27687457BACKGROUND

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

    PMID: 9059115BACKGROUND

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 28, 2016

Study Start

March 1, 2012

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 28, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)