Nasotracheal Intubation Over a Bougie

• Sponsor: University of Iowa (Other)
• Overall Status: Completed
• CT.gov ID: NCT03003455
• Collaborator: (none)
• Enrollment: 257
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasotracheal Intubation; Nasal Bleeding	Procedure: Nasotracheal intubation over a bougie; Procedure: Conventional Nasotracheal Intubation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Nasal trauma [60-90 seconds post-intubation]

   Bleeding noted on nasopharyngeal exam by surgical resident

Secondary Outcome Measures

1. Nasal trauma [5 minutes post-intubation]

   Bleeding noted on nasopharyngeal exam by surgical resident

2. Time to intubation [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 [Measured immediately post-intubation]

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

4. Need for Magill forceps [Measured Immediately post-intubation]

   Whether or not Magill forceps were used during airway management

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• University of Iowa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• O'Connell JE, Stevenson DS, Stokes MA. Pathological changes associated with short-term nasal intubation. Anaesthesia. 1996 Apr;51(4):347-50.

• Responsible Party: Abrons, Ron O, Assistant Professor of Anesthesiology, University of Iowa
• ClinicalTrials.gov Identifier: NCT03003455
• Other Study ID Numbers: 201112757
• First Posted: Dec 28, 2016
• Last Update Posted: Dec 28, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abrons, Ron O, Assistant Professor of Anesthesiology, University of Iowa: Nasotracheal Intubation
• Additional relevant MeSH terms: Epistaxis

Study Results

No Results Posted as of Dec 28, 2016