Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

Study Overview
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Brief Summary
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Uses the video stylet with different angulation to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea.

Detailed Description
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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. The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the nasotracheal tube passing the nasal cavity, oropharynx, and advanced into the tracheal. Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate nasotracheal tube sliding through into trachea and compared with each other group. Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea will be recorded. The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.

Official Title
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Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation

Conditions
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Intubation Complication

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing oro-maxillofacial surgery with general anesthesia(GA) ASA(American Society of Anesthesiologists):Ι to III 20-65 y/o mouth Open > 3cm the systemic disease exclusion conscious clear and without major Neurocognitive Disorder Mandarin or Taiwanese speaker agree the purpose of the study and sign the ICF Exclusion Criteria: difficult airway assessment [limited mouth opening<3cm, limited neck motion(thyromental distance < 6cm] previous head neck surgery history upper abnormal airway diagnosed, easily epistaxis, and both sides nasal cavities obstruction. reject to participate

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 45° group<br>Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea | |
| 70° group<br>Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea | |
| 90° group<br>Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of video stylet angulation and successful first tube attempt in 60 seconds | Time: TTI(time taken advancement) is less than 60 seconds in first tube attempt, it defines successful; TTI(time taken advancement) is over 60 seconds in first tube attempt, it defines unsuccessful. | During procedure | 
| success rate of video stylet angulation and successful first tube attempt in Lung's ventilation | Lung's ventilation: The lung's ventilation is success. | During procedure | 
| time taken advancement(TTI) | time taken advancement from nasal cavity into trachea in each time interval | During procedure | 
| assessment of difficult intubation(IDS) | Assessment of difficult intubation by Intubation Difficulty Scale(The Intubation Difficulty Scale, IDS, 1997) is required after intubation. Number of Attempts>1, score N1; Number of Operators >1, score N2; Number of Alternative Techniques, score N3; Comark Grade -1, score N4; Lifting Force Required Normal, score N5=0; Lifting Force Required Increased, score N5=1; Laryngeal Pressure Not applied, score N6=0; Laryngeal Pressure Applied, score N6=1; Vocal Cord Mobility Abducion, score N7=0; Vocal Cord Mobility Adducion, score N7=1. IDS=Sum of scores(N1-N7). If IDS score gains 0 means Easy, 0<IDS≤5 means Slight Difficulty, 5<IDS means Moderate to Major Difficulty, IDS=∞ means Impossible intubation. | During procedure | 
| assessment of Glottic grade(Cormack Grade) | Assessment of Glottic grade(Cormack Grade) is required after intubation. The definitions of grade: Grade 1: full view of the glottis; Grade 2a: partial view of the glottis; Grade 2b: arytenoids only; Grade 3: epiglottis only; Grade 4: neither glottis or epiglottis identified | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-intubation induced oropharyngeal bleeding, hoarseness and sore throat | A visiting questionnaire is used to measure the condition of post-intubation, including oropharyngeal bleeding, sore throat, hoarseness, dysphagia. The score for the measurement of oropharyngeal bleeding, sore throat, hoarseness, dysphagia is divided into four degrees: none, mild, moderate and severe. All the evaluation will be assessed in the next coming morning after the postoperation. | Day 2(the day after the operation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal intubation, Endotracheal Tube intubation General Anesthesia (ETGA), video stylet, angulation, nasotracheal intubation, trachway