Nasal Intubation：a Comparison of Different Endotracheal Tubes

Study Overview
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Brief Summary
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Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.

Detailed Description
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Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process. Randomly divided into two groups：Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes. Sedation process：Give Fentanyl 1 ug/kg according to the patient's weight via IV. Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding. Sedative injection：give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg Anesthesia intubation inducer：Propofol 1mg/kg Intubation Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation. Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation. Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.

Official Title
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Compare the Effects of Two Different Endotracheal Tubes on The Secretion and Bleeding Volume of Patients During Intubation to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope

Conditions
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Intubation Complication

Intervention / Treatment
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* Device: Henan Tuoren Endotracheal Tube
* Device: Smiths Portex Tracheal Tubes


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Henan Tuoren Endotracheal Tube group<br>Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea | Device: Henan Tuoren Endotracheal Tube<br>* The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.<br>|
| Experimental: Smiths Portex Tracheal tubes group<br>Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea | Device: Smiths Portex Tracheal Tubes<br>* The endotracheal tube is used under the direct view of the electronic imaging laryngoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea | 10 minutes | 
| time | 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-anesthesia care | post-intubation induced hoarseness and sore throat intubation related hoarseness and sorethroat at post-anesthesia care unit and the next coming morning | 2 days | 

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