Clinical trial NCT03003455: Nasotracheal Intubation Over a Bougie
Official title: Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasotracheal Intubation
Nasal Bleeding
Keywords: Nasotracheal Intubation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 257
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nasal trauma
timeFrame: 60-90 seconds post-intubation
Secondary outcomes:
measure: Nasal trauma
timeFrame: 5 minutes post-intubation
measure: Time to intubation
timeFrame: Measured immediately post-intubation
measure: First attempt success rate
timeFrame: Measured immediately post-intubation
measure: Need for Magill forceps
timeFrame: Measured Immediately post-intubation
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Cossham PS. Nasotracheal tube placement over a bougie. Anaesthesia. 1997 Feb;52(2):184-5. No abstract available.