Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal tube (PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom], Mallinckrodt TaperGuard [Covidien, Ireland]) depth in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral neck position.

Official Title
-----------------
Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes

Conditions
-----------------
Nasotracheal Intubation

Intervention / Treatment
-----------------
* Device: Portex
* Device: Mallinckrodt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Adult patients who undergoes elective surgery under general anesthesia with nasotracheal intubation Exclusion Criteria: Patients under 20 years old Patients with ASA class IV or higher Pregnant women Patients receiving emergency surgery Patients who have nasal disease or who undergo nose surgery because of nasal disease Patient with craniofacial anomaly Patients with impaired cervical motion Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner) Patients who refused the clinical trial Patients with dementia or cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portex<br>usage of PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube | Device: Portex<br>* nasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube.<br>|
| Active Comparator: Mallinckrodt<br>usage of Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube | Device: Mallinckrodt<br>* nasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position | whether the tube tip is located above the carina in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position). the distance from the carina to the tube tip in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position). | 1 minute after nasotracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adequacy of nasotracheal tube cuff location in extended and flexed neck position | whether the tube cuff is located below the vocal cords in extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords in neutral neck position. | 1 minute after nasotracheal intubation | 
| The adequacy of nasotracheal tube length | whether the tube cuff cannot be located 3cm below the vocal cords owing to short length of nasotracheal tube. | 1 minute after nasotracheal intubation |