Nasotracheal Intubation Over a Bougie

Not Applicable

Completed

• Conditions: Nasal Bleeding; Nasotracheal Intubation
• Interventions: Procedure: Conventional Nasotracheal Intubation; Procedure: Nasotracheal intubation over a bougie

• Registration Number: NCT03003455
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-12
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-21
• Last Update Submitted: 2016-12-21
• Study First Posted: 2016-12-28
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Nasotracheal Intubation (CVT)	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
Nasotracheal Intubation Over a Bougie (NIB)	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

Primary Outcome Measures

Name	Time	Method
Nasal trauma	60-90 seconds post-intubation	Bleeding noted on nasopharyngeal exam by surgical resident

Secondary Outcome Measures

Name	Time	Method
Nasal trauma	5 minutes post-intubation	Bleeding noted on nasopharyngeal exam by surgical resident
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
First attempt success rate	Measured immediately post-intubation	Whether or not there was successful nasotracheal intubation on the first attempt
Need for Magill forceps	Measured Immediately post-intubation	Whether or not Magill forceps were used during airway management

Trial Locations

Locations (1)

The University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States