Nasotracheal Intubation Over a Bougie

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

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.

Study Overview

• Status: Completed
• Conditions: Nasotracheal Intubation; Nasal Bleeding
• Intervention / Treatment: Procedure: Conventional Nasotracheal Intubation; Procedure: Nasotracheal intubation over a bougie

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	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; Other Names: CVT
EXPERIMENTAL: 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	Procedure: 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; Other Names: Abrons technique for nasotracheal intubation; Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet; NIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal trauma	Bleeding noted on nasopharyngeal exam by surgical resident	60-90 seconds post-intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal trauma	Bleeding noted on nasopharyngeal exam by surgical resident	5 minutes post-intubation
Time to intubation	Time from first entrance of ETT or bougie into the nare to the presence of end-tidal CO2 via nasotracheal ETT	Measured immediately post-intubation
First attempt success rate	Whether or not there was successful nasotracheal intubation on the first attempt	Measured immediately post-intubation
Need for Magill forceps	Whether or not Magill forceps were used during airway management	Measured Immediately post-intubation

Collaborators and Investigators

• Sponsor: University of Iowa

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (ESTIMATE): December 28, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 28, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Nasotracheal Intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Epistaxis
• Other Study ID Numbers: 201112757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO