The Effectiveness of Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Intubation

Study Overview
=================
Brief Summary
-----------------
either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx and advanced into the trachea

Detailed Description
-----------------
In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages. In addition, the advancement of the tube from oropharynx into trachea may assist by either using magic forceps or cuff inflation technique. The aim of the study is to investigate either use a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx, and advanced into the trachea. Patients were randomized into three groups by using either bougie or nasogastric tube to facilitate nasotracheal tube sliding through into trachea from assigned nostril and compared with the control group with a conventional technique. Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea were recorded. The incidence of using Magill Forceps to accurately place tube tip into trachea, intubation related side effects and complications were recorded at postoperative time stages.

Official Title
-----------------
Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope

Conditions
-----------------
Intubation Complication

Intervention / Treatment
-----------------
* Device: bougie
* Device: Nasogastric(NG) tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:20-65 years Undergoing oro-maxillofacial surgery Opening mouth > 3 cm Denied any systemic disease. American Society of Anesthesiologists (ASA) class:I-III Exclusion Criteria: Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance < 6cm) Previous head and neck surgery history Upper abnormal airway diagnosed Easily epistaxis Both sides nasal cavities obstruction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: bougie or nasogastric tube
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bougie group<br>The bougie group: The end of the endotracheal tube was guided to the glottis using the endotracheal tube in the bougie mode under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis. | Device: bougie<br>* The endotracheal tube is used in the bougie mode under the direct view of the electronic imaging laryngoscope.<br>|
| Experimental: Nasogastric(NG) tube group<br>NG tube group: The end of the endotracheal tube is guided to the glottis by using the endotracheal tube in the nasogastric tube under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis. | Device: Nasogastric(NG) tube<br>* The endotracheal tube is used in the NG tube mode under the direct view of the electronic imaging laryngoscope.<br>|
| No Intervention: control group<br>Control group: The general anesthesia method of placing the endotracheal tube through the nasal cavity is used to guide the tip of the endotracheal tube to the glottis under the direct view of the electronic imaging laryngoscope. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of tube advancement and successful first tube attempt | success rate of tube passing through nasal cavity into trachea | 10 minutes | 
| time taken in tube advancement | time taken in tube advancement from nostril into trachea in each time interval | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-intubation induced hoarseness and sore throat | A visiting questionnaire is used to measure the condition of post-intubation, including sore throat, hoarseness, dysphagia, nasal occlusion, nosebleed and nasal pain. The score for the measurement of sore throat, hoarseness, dysphagia is divided into four degrees: none, mild, moderate and severe; on the other hand, The score for the measurement of nasal occlusion, nosebleed and nasal pain is divided into yes or no. All the evaluation will be assessed in the next coming morning after the postoperation. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bougie, nasotracheal tube, Endotracheal Tube intubation General Anesthesia (ETGA)