Nasotracheal Intubation Over a Bougie
Primary Purpose
Nasotracheal Intubation, Nasal Bleeding
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasotracheal intubation over a bougie
Conventional Nasotracheal Intubation
Sponsored by
About this trial
This is an interventional treatment trial for Nasotracheal Intubation focused on measuring Nasotracheal Intubation
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
Sites / Locations
- The University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Nasotracheal Intubation (CVT)
Nasotracheal Intubation Over a Bougie (NIB)
Arm Description
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, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps
Outcomes
Primary Outcome Measures
Nasal trauma
Bleeding noted on nasopharyngeal exam by surgical resident
Secondary Outcome Measures
Nasal trauma
Bleeding noted on nasopharyngeal exam by surgical resident
Time to intubation
Time from first entrance of ETT or bougie into the nare to the presence of end-tidal CO2 via nasotracheal ETT
First attempt success rate
Whether or not there was successful nasotracheal intubation on the first attempt
Need for Magill forceps
Whether or not Magill forceps were used during airway management
Full Information
NCT ID
NCT03003455
First Posted
December 19, 2016
Last Updated
December 21, 2016
Sponsor
University of Iowa
1. Study Identification
Unique Protocol Identification Number
NCT03003455
Brief Title
Nasotracheal Intubation Over a Bougie
Official Title
Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasotracheal Intubation, Nasal Bleeding
Keywords
Nasotracheal Intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Nasotracheal Intubation (CVT)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Nasotracheal Intubation Over a Bougie (NIB)
Arm Type
Experimental
Arm Description
Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps
Intervention Type
Procedure
Intervention Name(s)
Nasotracheal intubation over a bougie
Other Intervention Name(s)
Abrons technique for nasotracheal intubation, Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, NIB
Intervention Description
Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps
Intervention Type
Procedure
Intervention Name(s)
Conventional Nasotracheal Intubation
Other Intervention Name(s)
CVT
Intervention Description
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
Primary Outcome Measure Information:
Title
Nasal trauma
Description
Bleeding noted on nasopharyngeal exam by surgical resident
Time Frame
60-90 seconds post-intubation
Secondary Outcome Measure Information:
Title
Nasal trauma
Description
Bleeding noted on nasopharyngeal exam by surgical resident
Time Frame
5 minutes post-intubation
Title
Time to intubation
Description
Time from first entrance of ETT or bougie into the nare to the presence of end-tidal CO2 via nasotracheal ETT
Time Frame
Measured immediately post-intubation
Title
First attempt success rate
Description
Whether or not there was successful nasotracheal intubation on the first attempt
Time Frame
Measured immediately post-intubation
Title
Need for Magill forceps
Description
Whether or not Magill forceps were used during airway management
Time Frame
Measured Immediately post-intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11753001
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.
Results Reference
background
PubMed Identifier
8686823
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.
Results Reference
background
PubMed Identifier
16527796
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.
Results Reference
background
PubMed Identifier
27687457
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.
Results Reference
background
PubMed Identifier
9059115
Citation
Cossham PS. Nasotracheal tube placement over a bougie. Anaesthesia. 1997 Feb;52(2):184-5. No abstract available.
Results Reference
background
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Nasotracheal Intubation Over a Bougie
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